Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of nutraceutical formulations. More particularly, the present invention pertains to an oral formulation designed to alleviate stomach discomfort and reduce stress.
BACKGROUND
[0002] Due to major changes in lifestyle, the number of gastrointestinal diseases and illnesses has increased during the past decades. High rates of anxiety, stress, sadness, and compromised central nervous system function are frequently observed in people with gastrointestinal disorders. A National Library of Medicine analysis states that the overall prevalence of self-reported gastrointestinal issues is 18%, with substantial geographical variations and a noticeable rise in men's age. Gastrointestinal problems are more common in those with neurological or psychiatric disorders (27%), than in people with cardiac disease (23%), or hypertension (22%). By providing a holistic solution to enhance gut health and lessen associated stress and discomfort, this invention seeks to address and alleviate these gastrointestinal issues.
[0003] Various prior arts have explored different compositions and applications of herbal and probiotic formulations aimed at stress relief, gut health, and overall well-being. For instance, in a patent literature CN104206903A discloses a Chinese herbal medicine anti-stress agent composition. The Chinese herbal medicine anti-stress agent composition comprises the following components in parts by weight: 1-10 parts of astragalus polysaccharide, 5-15 parts of a Chinese magnoliavine fruit extract, 1-9 parts of a spina date seed extract, 1-9 parts of a barbary wolfberry fruit extract, 1-5 parts of a honeysuckle flower extract, 0.2-3 parts of a saffron extract, 2-12 parts of glutamine dipeptide, 1-5 parts of stable Vc and the balance of corncobs, wherein the corncobs are taken as a carrier. The Chinese herbal medicine anti-stress agent composition is applied as a feed additive. The feed is used for culturing fishes such as yellow catfishes, grass carps or breams. Through adoption of the Chinese herbal medicine anti-stress agent composition, the pathogenic microorganism resistance and environmental stress resistance of aquaculture varieties can be improved, so that the survival rate in total-lifecycle culture is increased. This composition enhances the resistance of aquaculture varieties to pathogenic microorganisms and environmental stress, thereby increasing their survival rate throughout their lifecycle. Although effective for aquaculture, this formulation is not directly applicable to human health concerns, particularly stress and gut health.
[0004] In another patent literature, JP2014015480A relates to the use of saffron and/or its active ingredients, such as saffron and/or picrocrocin and/or crocin and/or derivatives thereof in production of an active satiation agent for treating and/or coping with problems of overweight and in production of an active satiation agent for management and/or treatment of eating disorder with compulsive nibbling cravings linked to stress and/or depression. Therefore, this treatment addresses weight problems linked to stress and depression without requiring lifestyle or dietary changes. However, while this prior art highlights the benefits of saffron in managing stress-related eating disorders, it does not address broader digestive health issues or provide a comprehensive solution for stress reduction.
[0005] In another patent literature, CN112869162A describes a composite herbal oligopeptide composition with anti-fatigue and sleep-aiding functions and a preparation method thereof, and the composition comprises the following components in parts by mass: 5-10 parts of gamma-aminobutyric acid, 1-5 parts of L-theanine, 15-35 parts of a traditional Chinese medicine extract, 1-5 parts of a saffron crocus extract, 1-5 parts of passion flower powder, 15-30 parts of composite oyster peptide microcapsules, 10-25 parts of wheat oligopeptide, 1-5 parts of casein hydrolyzed peptide, 1-5 parts of walnut peptide and 5-10 parts of Monte-Molenic acid cherry powder. The raw materials of the traditional Chinese medicine extract comprise fried semen ziziphi spinosae, poria cocos, cortex cinnamomi, liquorice root and fructus ziziphi jujubae. According to the invention, a new day and night mode of resisting fatigue in the daytime and helping sleep at night can be realized, and the composite oyster peptide microcapsules adopt double layers and play a slow release role, so that the effects of resisting fatigue in the daytime and helping sleep at night are further promoted, and the demands of resisting fatigue, relieving pressure and improving sleep are fundamentally met. Although effective for fatigue and sleep improvement, this composition does not focus on relieving gastrointestinal discomfort or providing an easy-to-administer format like an oral administration.
[0006] Further, another patent literature CH710953B1 presents a food composition containing a saffron petal extract. Saffron petal extract gives the food composition a pleasant taste and makes it invigorating and refreshing. In addition, the food composition according to the invention also has a stress-inhibiting effect and strengthens the immune system. This prior art underscores the stress-relief benefits of saffron but does not combine it with other elements essential for comprehensive gut health.
[0007] Another patent literature CN116492377A discloses application of lactobacillus acidophilus LA-03 in preparation of a medicine for preventing or treating intestinal inflammation, and belongs to the technical field of microorganisms. According to the application of the lactobacillus acidophilus LA-03 in preparation of the medicine for preventing or treating the intestinal inflammation, disclosed by the invention, the lactobacillus acidophilus LA-03 can be used for inhibiting DSS from inducing neutrophile granulocytes to gather towards the intestinal tract of zebra fish, so that a theoretical reference and a guidance basis are provided for developing the medicine for preventing or treating the intestinal inflammation by utilizing the lactobacillus acidophilus LA-03. This invention focuses on a specific strain of probiotics for a particular gastrointestinal issue, whereas the present invention incorporates a broader spectrum of for general gut health and stress reduction.
[0008] Furthermore, another patent literature KR101795499B1 relates to a fermented total mixed ration (TMR) feed for ruminants using lactobacillus strain combinations with improved availability in ruminants of fiber TMR feed for only ruminants. The TMR feed is fermented by combining Lactobacillus paracasei and Lactobacillus plantarum strains so the production amount of acetic acid, propionic acid and butyrate which are volatile fatty acids in the ruminant stomach is increased when compared to using only a lactobacillus strain or combining other lactobacillus strains. While this composition is effective for animal health, its application and benefits for human health, particularly in stress reduction and gut health, are not addressed.
[0009] Additionally, in another patent literature, IN202041019535 discloses a probiotic formulation for lowering stress, anxiety and depression, said formulation comprising at least a non-essential amino acid and a consortium of probiotic microbes, said consortium further comprising Bacillus sp., Lactobacillus sp. and Bifidobacterium sp. wherein, the said microbes are non-pathogenic to humans and animals and wherein at least one of the said microbes is capable of degrading the said non-essential amino acid to produce an inhibitory neurotransmitter and the said neurotransmitter lowers stress, anxiety and depression in an individual. Such formulation addresses mental health issues related to neurotransmitter imbalances but does not provide immediate relief for digestive discomfort or incorporate prebiotics, probiotics, and saffron extract in a convenient mouth-dissolving format.
[0010] While these prior arts contribute significantly to their respective fields, but the existing technologies are devoid of ensuring a synergistic effect of prebiotics and probiotics that can promote comprehensive gut health and alleviate stress. Further, the existing techniques nowhere discloses about the enhanced bioavailability of the active ingredients due to the format of the respective formulation, herby ensuring faster onset of action.
[0011] Therefore, in order to avoid such problems, there is a need for a novel and advanced nutraceutical formulation that addresses common gastrointestinal issues and provides effective stress relief through a unique blend of ingredients. The present disclosure is directed to overcome one or more limitations stated above, and any other limitation associated with the prior arts.
SUMMARY
[0012] One or more shortcomings of the prior art are overcome, and additional advantages are provided through the present disclosure. Additional features and advantages are realized through the techniques of the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein and are considered a part of the claimed disclosure.
[0013] The present invention is directed to a nutraceutical formulation for alleviating stomach discomfort and reducing stress. The formulation comprises saffron (Crocus sativus) extract; licorice (Glycyrrhiza glabra) extract; bael (Aegle marmelos) extract; inulin; sodium bicarbonate; probiotic blend; peppermint oil extract; and pharmaceutically acceptable excipients. In one embodiment, the pharmaceutically acceptable excipients include a diluent, a bulking agent, a sweetener, a humectant, a stabilizer, an acidity regulator, a flavor enhancer, and an anti-caking agent.
[0014] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
BRIEF DESCRIPTION OF DRAWINGS
[0015] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary embodiments and, together with the description, explain the disclosed principles. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The same numbers are used throughout the figures to reference like features and components. Some embodiments of system and/or methods in accordance with embodiments of the present subject matter are now described, by way of example only, and regarding the accompanying figures, in which:
[0016] Figure 1A – Figure 1O illustrates exemplary representations of assessments of gut using different gastrointestinal symptoms rating scale score, in accordance with some embodiments of the present disclosure.
[0017] The figures depict embodiments of the disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the disclosure described herein.
DETAILED DESCRIPTION
[0018] In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.
[0019] While the disclosure is susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below. It should be understood, however that it is not intended to limit the disclosure to the specific forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternative falling within the scope of the disclosure.
[0020] The terms “comprises”, “comprising”, “includes”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, device, or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or method. In other words, one or more elements in a system or apparatus proceeded by “comprises… a” does not, without more constraints, preclude the existence of other elements or additional elements in the system or method.
[0021] The present invention aims to develop a nutraceutical formulation in the form of an oral administration that includes powdered tropical fruit, soluble fiber from plants, licorice extract, saffron extract, and a probiotic blend. The creation of a stable nutraceutical formulation that provides immediate relief from indigestion, bloating, and acidity is another objective of the present invention. Additionally, the present innovation offers a nutraceutical composition free of artificial coloring and added sugars that supports intestinal health and lowers stress.
[0022] Also, the object of the present invention is to address the interconnected relationship between gut health and mental health. The formulation targets both gut health and stress simultaneously by leveraging the gut-brain axis, a bidirectional communication network between the gastrointestinal tract and the central nervous system. By enhancing gut health through the inclusion of saffron, probiotics, Licorice extract, a soluble fibre found in plants and powder of a tropical fruit, the formulation supports a balanced microbiome, which plays a crucial role in regulating stress and promoting mental well-being. Such comprehensive approach ensures that the user experiences relief from digestive issues while benefitting from reduced stress levels.
[0023] In the following detailed description of the embodiments of the disclosure, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the present disclosure. The following description is, therefore, not to be taken in a limiting sense.
[0024] The present invention provides a synergistic composition comprising herbal extracts of Saffron, licorice, Bael, Inulin, Peppermint oil, chemical compound of Sodium bicarbonate and a probiotic blend of Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis along with pharmaceutically acceptable excipients, wherein such composition provides a quick relief from acidity, bloating, and indigestion while promoting gut health and reducing stress without any artificial colors or added sugars.
[0025] The antioxidant and stress-relieving qualities of saffron extract are well-known. Saffron extract, a key component, is derived from the vibrant red stigma of the flower, scientifically known as Crocus sativus. In addition to its possible health benefits, such as stress relief and antioxidant qualities, saffron extract is valued for its unique flavor, aroma, and vivid color.
[0026] Glycyrrhiza glabra, the technical name for licorice extract, has been clinically shown to enhance gut immunity and digestive health while reducing bloating and acidity.
[0027] Further, bael extract, formally known as Aegle marmelos, lowers inflammation and enhances gastrointestinal health. The tropical bael fruit's leaves and bark are used to make bael extract, which is well known for having a major positive effect on intestinal health. It facilitates a healthy gut microbiome, avoids constipation, and helps with digestion.
[0028] Inulin is a prebiotic fiber that promotes regular digestion and feeds good gut bacteria. Inulin functions as a prebiotic and is present in several plants.
[0029] Sodium bicarbonate is a chemical ingredient that helps in neutralizing stomach acid and relieving indigestion.
[0030] The probiotic blend comprising Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis that promotes gut health and replenishes good bacteria.
[0031] Peppermint oil extract, scientifically known as Mentha piperata L., is utilized for its calming effects on the digestive tract and capacity to alleviate stomach symptoms.
[0032] Pharmaceutically acceptable excipients are the substances other than the active drug, used in pharmaceutical dosage forms. The excipients are considered as inert substances, they do not have any active role in therapeutics, but they can be used to support the process to produce an effective product. In this present formulation used pharmaceutically excipients belong to a group consisting of diluent, bulking agent, stabilizer, sweetener, humectant, acidity regulator, flavour enhancer, anti-caking agent etc. enhancing the taste, stability and effectiveness of the formulation as excipients.
[0033] In one embodiment, the diluent is selected from a group consisting of one of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, tricalcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, and Sodium starch glycolate. The bulking agent is selected from a group consisting of one of Anhydrous Lactose, Sucrose, Rice flour, Mannitol, Sorbitol, Sodium Chloride, Calcium sulphate, Kaolin, Dicalcium Phosphate, and Cellulose. The sweetener is selected from a group consisting of one of Acesulfame potassium, Saccharin, Aspartame, Sucralose, Neotame, Sorbitol, Cyclamat, Xylitol, Advantame, Alitame, Lactitol, Sugar, Erythritol, Maltitol, Mannitol, Fructose, Glucose, Glycyrrhizin, Maltose, Neohesperidin dihydrochalcone, Stevioside, Tagatose, and Thaumatin.
[0034] Additionally, the humectant is selected from a group consisting of one of Xylitol, sodium malate, sodium lactate, sorbitol. The stabilizer is selected from a group consisting of one of PVP (Povidone), PVA (Polyvinyl alcohol), PEG (Polyethylene glycol), HPMC (Hypromellose), HPC (Hydroxypropyl cellulose), HEC (Hydroxyethyl cellulose), NaCMC (Carboxymethylcellulose sodium), SD (Docusate sodium), SLS (Sodium lauryl sulfate), PEI (Polyethylene imine), TPGS (D-α-tocopheryl polyethylene glycol succinate), PEO (Polyethylene oxide), and PPO (Polypropylene oxide).
[0035] Further, the acidity regulator is selected from a group consisting of one of Sodium salts, Sorbic acid, Acetic acid, Benzoic acid, Citric acid, and Propionic acid. The flavor enhancer is selected from a group consisting of one of Vanillin, Ethyl vanillin, Maltol, Ethyl maltol, or any naturally derived flavor. Furthermore, the anti-caking agent is selected from a group consisting of one of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Silicon dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, and Yellow prussiate of soda.
[0036] The unique combination of these ingredients in precise amounts creates a powerful nutraceutical formulation aimed at improving gut health and reducing stress. The inclusion of prebiotic fibers ensures a balanced gut microbiome, which is essential for overall well-being. Additionally, the formulation provides immediate relief from common digestive problems like indigestion, bloating, and acidity.
[0037] In an embodiment of the present invention, the formulation is in the form of an oral formulation, providing convenient and quick relief from digestive discomfort and stress.
[0038] The present invention provides a nutraceutical formulation comprising Saffron extract, Licorice extract, Bael extract, Inulin, Sodium bicarbonate, Probiotic blend, Peppermint oil extract.
[0039] The source and geographical origin of the aforesaid component is as listed below as in Table 1.
Common Name Scientific name Part Used Geographical Origin
Saffron Crocus sativus L. Stigma/ style France
Licorice extract Glycyrrhiza glabra Root extract India
Bael Aegle marmelos (L.) Corr. Fruit India
Inulin Inulin Fiber India
Sodium bicarbonate Sodium bicarbonate Chemical compound India
Probiotic blend Probiotic Blend of Lactobacillus acidophilus, Lacticaseibacillus paracasei, Bifidobacterium lactis Probiotic blend India
Peppermint Mentha piperita L./ Mentha spp. Oil extract India
Table 1
[0040] In the present invention stigma of saffron (Crocus sativus), roots of Licorice (Glycyrrhiza glabra), fruits of Bael (Aegle marmelos) in powder form, certain plants for Inulin, leaves of Mentha piperita are used for preparing the respective extracts. The herbal extracts are prepared by using solvents selected from ethanol, methanol and water.
[0041] Sodium bicarbonate reduces stomach acid. It is used as an antacid to treat heartburn, indigestion, and upset stomach. Sodium bicarbonate is a very quick-acting antacid. Sodium Carbonate is the disodium salt of carbonic acid with alkalinizing property. When dissolved in water, sodium carbonate forms carbonic acid and sodium hydroxide. As a strong base, sodium hydroxide neutralizes gastric acid thereby acting as an antacid.
[0042] The probiotic blend of Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis that replenishes beneficial bacteria and supports gut health. The probiotic blend is composed of 4 bacterial strains, Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-07 and B. lactis Bi-04, in equal amounts. In human experiments, the strains have been shown to alleviate gastrointestinal symptoms like bloating, constipation, and stomach pain. They can also perform a variety of probiotic functions, including immune-modulating, anti-inflammatory, and pathogen-exclusion.
[0043] In one embodiment, the present invention discloses a synergistic composition comprising herbal extracts of:
1. the Crocus sativus in an amount of 0.50% to 1.50% by weight
2. the Glycyrrhiza glabra in an amount of 3.00% to 6.00%
3. the Aegle marmelos in an amount of 5.00% to 10.00% by weight
4. the Sodium Bicarbonate in an amount of 1.00% to 2.00% by weight
5. the Probiotic Blend in an amount of 2.00% to 4.00% by weight, wherein the Probiotic Blend includes Lactobacillus acidophilus, Lactobacillus paracasei, and Bifidobacterium lactis;
6. the Peppermint Oil Extract in an amount of 1.00% to 2.50% by weight;
7. the Inulin in an amount of 15.00% to 25.00% by weight of the total weight of the composition and pharmaceutically acceptable excipients.
[0044] Further, the pharmaceutical acceptable excipients used in the present invention are:
1. the diluent in an amount ranging from 1.5% to 3.5% by weight;
2. the bulking agent in an amount ranging from 10% to 20% by weight;
3. the sweetener in an amount ranging from 0.1% to 1.0% by weight;
4. the humectant in an amount ranging from 25% to 40% by weight;
5. the stabilizer in an amount ranging from 1% to 2% by weight;
6. the acidity regulator in an amount ranging from 2% to 3% by weight;
7. the flavor enhancer in an amount ranging from 4% to 5% by weight;
8. the anti-caking agent in an amount ranging from 0.5% to 1% by weight of the total weight of the composition.
[0045] In an exemplary embodiment, the synergistic composition comprises herbal extracts of:
1. Crocus sativus L. in an amount of 0.86% by weight;
2. Glycyrrhiza glabra in an amount of 4.29% by weight;
3. Bael (Aegle marmelos (L.) Corr.) in an amount of 7.14% by weight;
4. Inulin in an amount of 21.43% by weight;
5. Sodium bicarbonate in an amount of 1.29% by weight;
6. Probiotic Blend in an amount of 2.86% by weight;
7. Peppermint Oil Extract in an amount of 1.80% by weight.
[0046] In the exemplary embodiment, the pharmaceutical acceptable excipients used in the present invention are:
1. the diluent in an amount of 16.29% by weight;
2. the bulking agent in an amount of 29.91% by weight;
3. the sweetener in an amount of 0.15% by weight;
4. the humectant in an amount of 4% by weight;
5. the stabilizer in an amount of 1.43% by weight;
6. the acidity regulator in an amount of 3.43% by weight;
7. the flavor enhancer in an amount of 2.83% by weight;
8. the anti-caking agent in an amount of 2.29% by weight.
[0047] Accordingly, in another exemplary embodiment, the present invention discloses a synergistic composition comprising herbal extracts of:
1. Saffron extract in an amount of 25.00 mg to 45.00 mg;
2. Licorice extract in an amount of 125.00 mg to 175.00 mg;
3. Bael extract in an amount of 225.00 mg to 275.00 mg;
4. Inulin in an amount of 700.00 mg to 800.00 mg;
5. Sodium bicarbonate in an amount of 40.00 mg to 60.00 mg;
6. Probiotic blend with Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-07, Bifidobacterium lactis Bl-04 in an amount of 90.00 mg to 110.00 mg;
7. Peppermint oil extract in an amount of 55.00 mg to 70.00 mg of the total weight of the composition and pharmaceutically acceptable excipients.
[0048] In another exemplary embodiment, the present invention discloses a synergistic composition comprising herbal extracts of;
1. Saffron extract in an amount of 30 mg;
2. Licorice extract in an amount of 150 mg;
3. Bael extract in an amount of 250 mg;
4. Inulin in an amount of 750 mg;
5. Sodium bicarbonate in an amount of 45 mg;
6. Probiotic blend in an amount of 100 mg;
7. Peppermint oil extract in an amount of 63 mg of the total weight of the composition and pharmaceutically acceptable excipients contained in a sachet having net quantity of 3.5 g.
[0049] The formulation is designed to provide relief from digestive discomforts such as acidity, bloating, and indigestion while simultaneously reducing stress levels. Each ingredient in the formulation plays a critical role in enhancing gut health and promoting overall well-being.
[0050] The end product is an oral formulation that is easy to consume and effective in delivering the intended health benefits.
[0051] In an embodiment of the invention, the nutraceutical formulation is designed to be non-habit forming, free from artificial colors, and contains no added sugar. It is clinically proven to reduce stress by 57.54% and revitalizes gut health in just 30 days. The unique blend of ingredients ensures comprehensive support for a balanced and thriving gut microbiome, promoting a happier and healthier life.
[0052] In another embodiment, the process involved in the preparation of the proposed nutraceutical formulation includes accurately weighing all the active ingredients and sifting through vibrio sifter. The process includes mixing all ingredients in cone mixer and passing the blend through the 40 CFM (Cross Flow Microfiltration) sleeve. The process further comprises mixing the additives including peppermint oil extract, sodium bicarbonate, mannitol, sorbitol powder and Howaru one by one, and passing the mixture through sifter. Further, after QC testing, the mixture is packed in sachets.
Experimental and Clinical Trial Details:
[0053] A study has been conducted on individuals experiencing mild stress, aged between 20 to 40 years, to assess the compliance, clinical, vital parameter assessment, and tolerability of the probiotic formulation. The trial was an open-label, single-arm, safety study, with each subject receiving serving of the formulation daily after a meal for 30 days. Ethics committee approval was obtained, and the study was conducted in accordance with ICH-GCP guidelines. Written informed consent was obtained from all participants before enrollment. The trial was registered on the CTRI website, and enrollment began after registration. The study aimed to evaluate changes in complete blood count (CBC), liver function test (LFT), and renal function test (RFT) parameters, as well as gut health and perceived stress levels using standardized scales. Adverse events were also monitored throughout the study period.
[0054] A study protocol and related documents underwent review and approval by the ethics committee (EC) before subject recruitment. Subjects were enrolled only after EC approval, and there were no protocol changes post-approval. The study was initiated after obtaining written approval from the Institutional Ethics Committee (IEC) of Lokmanya Medical Research Centre, Chinchwad, Pune, Maharashtra, India (ECR/175/Inst/MH/2013/RR-19), and conducted in accordance with the approved protocol and ICH-Good Clinical Practices (GCP) guidelines.
[0055] The study adhered strictly to ICH-GCP guidelines. Throughout the trial, the rights, safety, and well-being of participants were paramount. Investigational products were prepared in compliance with Good Manufacturing Practices (GMP) as applicable in India.
[0056] Voluntary written informed consent was obtained from subjects prior to their participation in the study. The informed consent process included a detailed explanation of the study objectives, design, risks, and benefits. For illiterate subjects, an impartial witness read and explained the Informed Consent Form (ICF) in the language understood by the subject. Thumb impressions of illiterate subjects and signatures of impartial witnesses were obtained on the ICF. Subject identities were kept confidential, and study data was coded. The results of the study may be published in peer-reviewed scientific journals with investigators' consent, without disclosing subject identities.
[0057] The study's primary objectives were to evaluate the compliance, clinical parameters, vital signs, and tolerability of the investigational product from baseline to the end of the study. Additionally, changes in CBC, LFT, and RFT parameters were assessed at screening and on day 30, along with the monitoring of adverse events throughout the study period. Secondary objectives included assessing changes in gut health using the Gastrointestinal Symptom Rating Scale (GSRS) score at screening and the end of the study, as well as evaluating changes in perceived stress using the Perceived Stress Scale (PSS) score questionnaire at screening and on day 30.
[0058] To ensure the study's relevance and reliability, specific inclusion and exclusion criteria were established for participant selection. The respective inclusion criteria and exclusion criteria are illustrated below.
[0059] Inclusion Criteria:
1. Male and female individuals aged between 20 to 40 years (both inclusive).
2. Female subjects with a negative urine pregnancy test before screening.
3. Subjects with a BMI between 18.5 – 29.9 kg/m2.
4. A subject suffering from mild stress on PSS.
5. Subjects should self-report at least two of the following gastrointestinal symptoms: epigastric discomfort, heartburn, bloating, nausea, fullness in the stomach, abdominal pain, or anorexia.
6. Subjects who are not consuming probiotics, prebiotics, etc.
7. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
8. Subjects are willing to follow up.
[0060] Exclusion Criteria:
1. Women with childbearing potential and not taking adequate contraceptive precautions.
2. Pregnant or lactating women.
3. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking.
4. Participants with neurological conditions or gone through recent surgeries.
5. Participants with comorbidities or with clinical insomnia.
6. The subjects consuming any ayurvedic or nutraceutical supplement for said indications for the last three months.
7. Any other clinical condition in the judgment of the investigator finds the study participation unsuitable for the participant.
Result of the Study:
[0061] Demographic characteristics – All thirty participants (18 males and 12 females) successfully completed the study, with an average age of 31.00 (± 5.69) years and no statistically significant difference between genders. Male participants had an average weight of 67.83 kg, a height of 167.11 cm, and a BMI of 24.31 kg/m2, while female participants had an average weight of 55.83 kg, a height of 157.08 cm, and a BMI of 22.65 kg/m2. These demographic details are summarized in Table 2.
Demographic Details Male Female P Value
Average Age (Years) 31.78 ± 5.44 29.83 ± 6.09 0.368
Anthropometric Parameters
Height (cm) 167.11 ± 9.96 157.08 ± 5.63 0.003*
Weight (kg) 67.83 ± 10.04 55.83 ± 8.16 0.018*
BMI (kg/m2) 24.31 ± 3.23 22.65 ± 3.32 0.182
Table 2
The data in Table 2 is represented as Mean ± S.D. The analysis was done using the Independent student t-test, where it was significant at p< 0.05.
[0062] Assessment of hematological and biochemical investigations – Statistically significant increases were observed in white blood cell count, red blood cell count, hematocrit, mean corpuscular volume, neutrophils, alanine transaminase, and alkaline phosphatase. However, these changes were not clinically significant, indicating that the investigational product was well-tolerated by the study participants. No statistically or clinically significant changes were observed in other hematological and biochemical parameters, all of which remained within normal ranges before and after the use of the investigational product as illustrated in Table 3.
Parameter Screening Day 30 Reference Range P Value
White Blood Cell Count (cell/cu.mm) 7770.67 ± 2137.22 8996.00 ± 2878.58 4000 - 11000 cell/cu.mm 0.009* 0.093*
Red Blood Cell Count (mil/cu.mm) 4.93 ± 0.86 5.23 ± 0.58 4.7 - 6.0 mil/cu.mm 0.009* 0.002*
Hematocrit (%) 40.31 ± 6.97 42.44 ± 4.78 42 - 52 % 0.399
Mean Corpuscular Volume (fL) 82.64 ± 14.28 86.45 ± 10.07 78 - 100 fL 0.434
Mean Corpuscular Haemoglobin (pg) 26.10 ± 5.37 27.04 ± 3.23 27 - 31 pg 0.016*
Platelet Count (10^3/u) 313.17 ± 76.82 298.67 ± 58.64 150 - 450 10^3/u 0.914
Neutrophils (%) 59.53 ± 7.38 63.30 ± 7.60 40 - 75 % 0.218
Lymphocytes (%) 32.33 ± 7.18 32.47 ± 5.84 20 - 40 % 0.638
Monocytes (%) 5.10 ± 1.37 5.43 ± 0.90 2 - 10 % 1
Eosinophils (%) 3.37 ± 0.72 3.47 ± 0.82 1 - 6 % 0.773
Basophils (%) 0.00 ± 0.00 0.00 ± 0.00 0 - 1 % 0.269
Protein Total (g/dL) 7.35 ± 0.76 7.58 ± 0.67 6.0 - 8.3 g/dL 0.304
Albumin (g/dL) 4.32 ± 0.37 4.41 ± 0.31 3.2 - 5.5 g/dL 0.381
Globulin (g/dL) 3.04 ± 0.78 3.17 ± 0.62 1.8 - 3.6 g/dL 0.987
A/G Ratio 1.53 ± 0.50 1.45 ± 0.33 1.2 - 2.2 0.895
Bilirubin Total (mg/dL) 0.59 ± 0.34 0.59 ± 0.23 0.1 - 1.2 mg/dL 0.946
Bilirubin Direct (mg/dL) 0.25 ± 0.13 0.26 ± 0.10 0 - 0.4 mg/dL 0.236
Bilirubin Indirect (mg/dL) 0.34 ± 0.24 0.34 ± 0.21 0.1 - 0.8 mg/dL 0.008*
Aspartate Transaminase (U/L) 37.20 ± 11.92 36.08 ± 8.68 10 - 50 U/L 0.018*
Alanine Transaminase (U/L) 31.66 ± 13.92 33.95 ± 11.51 10 - 50 U/L 0.002*
Alkaline Phosphatase (U/L) 142.29 ± 44.06 155.24 ± 49.25 80 - 306 U/L 0.684
Urea (mg/dL) 21.40 ± 7.42 25.64 ± 10.40 10 - 50 mg/dL -
Creatinine (mg/dL) 0.86 ± 0.19 0.83 ± 0.23 Female: 0.6-1.4 & Male: 0.7-1.4 mg/dL -
Uric Acid (mg/dL) 4.25 ± 0.91 4.07 ± 0.78 3.0 to 7.2 mg/dL 0.298
Table 3
The data in Table 3 is represented as Mean ± S.D. The analysis was done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group), wherein it was significant at p< 0.05.
[0063] Assessment of vital signs – Body temperature exhibited a statistically significant increase from screening to day 30 (97.17 ± 0.94, p = 0.0279). However, other vital parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate did not show statistically significant changes from screening to day 30, as indicated in Table 4.
Vital Sign Screening Day 30 P value
Systolic Blood Pressure 122.53 ± 6.04 121.40 ± 7.97 0.509
Diastolic Blood Pressure 80.80 ± 5.94 80.37 ± 6.71 0.801
Heart Rate 75.17 ± 6.47 78.20 ± 9.00 0.186
Body Temperature 96.50 ± 1.77 97.17 ± 0.94 0.027*
Respiratory Rate 17.90 ± 1.35 19.90 ± 9.74 0.234
Table 4
The data in Table 4 is represented as Mean ± S.D. The analysis was done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group), wherein it was significant at p< 0.05.
[0064] Assessment of adverse events – The adverse events observed during the study are presented in Table 5. Out of the 30 participants, a total of 7 subjects (23.33%) experienced at least one adverse event. The most commonly reported adverse events were headache, nausea, fever, heartburn, body pain, sneezing, and acidity. For each adverse event, the number of subjects affected and the corresponding rescue medication used are shown. These adverse events were not related to the investigational product.
Adverse Event No. of Subjects (N=30) Rescue Medication
Headache 1 Nicipplus
Nausea 1 Pantosec D SR
Fever 1 Crocin 500
Heartburn 1 Pan D
Body pain 1 Dolo 650
Sneezing 1 -
Acidity 1 Pantosec DSR
Total 7 -
Total No. of subjects (%) 7 (23.33%) -
Table 5
[0065] Assessment of perceived stress using perceived stress scale – The Perceived Stress Scale (PSS) comprises ten questions, with responses ranging from 0 to 4, used to measure an individual's perception of stress. The total score, derived from summing all responses, indicates the level of perceived stress: 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress). The assessment of perceived stress using the PSS revealed a statistically significant 57.54% decrease from the screening visit to day 30, as shown in Table 6. This observed change in PSS score was highly significant, suggesting a clinically meaningful improvement in participants' subjective experience of stress.
Duration Screening Day 30 P value
PSS Score 24.57 ± 1.59 10.43 ± 1.98 <0.001*
Table 6
The data in Table 6 is represented as Mean ± S.D. The analysis was done using a dependent student t-test (within the group). Significant at p < 0.05.
[0066] Assessment of gut using a gastrointestinal symptom rating scale score – The Gastrointestinal Symptom Rating Scale (GSRS) is a disease-specific instrument designed to assess common symptoms of gastrointestinal disorders. It consists of 15 items, each rated on a seven-point Likert scale as: 1- no discomfort at all; 2-minor discomfort, 3-mild discomfort; 4-moderate discomfort; 5-moderately severe discomfort; 6- severe discomfort; 7-very severe discomfort. The scale allows for the evaluation of symptoms such as abdominal pain, bloating, nausea, and other gastrointestinal issues commonly experienced by individuals with digestive disorders.
[0067] The analysis of gastrointestinal symptoms using the GSRS revealed significant improvements in patients' gut health over the course of the study, as detailed in Table 7 and further illustrated in Figures 1A – 1O. Patients reported reduced pain or discomfort in the upper abdomen, decreased instances of heartburn, acid reflux, hunger pains, nausea, rumbling, bloating, burping, gas/flatus, hard stools, incomplete bowel emptying, diarrhea, loose stools, urgent bowel movements, and constipation by the study's conclusion. These findings indicate the effectiveness of the interventions in improving overall gut health and alleviating gastrointestinal symptoms among the participants.
Question 1:
[0068] Observation: Regarding the question about pain or discomfort experienced during the past week, the data shows that at the screening (n=30), 14 participants reported mild pain or discomfort in their upper abdomen or the pit of their stomach, 9 reported moderate pain or discomfort, and 6 reported moderately severe pain or discomfort. After receiving the treatment on day 30, 7 participants completely resolved the symptoms. While, 19 participants reported only minor pain or discomfort, and only 4 reported mild pain or discomfort.
[0069] Conclusion: Pain or discomfort reduced from moderate-to-mild levels at screening to primarily minor discomfort by day 30.
Question 2:
[0070] Observation: Regarding the question about heartburn experienced during the past week, the data shows that at the screening (n=30), the distribution of heartburn severity was as follows: 12 participants reported moderate heartburn, 11 reported mild heartburn, and 5 reported minor heartburn. However, by day 30 (n=30), the heartburn symptoms had generally improved, with 19 participants reporting only minor heartburn, only 4 reporting mild heartburn and 7 reporting no heartburn at all.
[0071] Conclusion: Heartburn decreased from moderate-to-mild levels at screening to mostly minor or no heartburn by day 30.
Question 3:
[0072] Observation: Regarding the question about acid reflux experienced during the past week, the data shows that at the screening (n=30), the majority of participants reported minor to moderate levels of acid reflux, with 13 participants reporting minor acid reflux, 6 reporting moderately severe acid reflux, and 5 reporting moderate acid reflux. In contrast, by day 30 (n=30), the severity of acid reflux had significantly decreased, with 16 participants reporting no acid reflux at all and 12 reporting only minor acid reflux.
[0073] Conclusion: Acid reflux improved from minor-to-moderate reflux at screening to predominantly no or minor reflux by day 30.
Question 4:
[0074] Observation: Regarding the question about hunger pains experienced in the stomach during the past week, the data shows a clear improvement in symptoms from the screening (n=30) to day 30 (n=30). At the screening, the majority of participants, 21, reported no hunger pains at all, while 8 reported minor hunger pains, and only 1 reported mild hunger pains. By day 30, all 30 participants reported no hunger pains.
[0075] Conclusion: Hunger pains improved to predominantly no hunger pain by day 30.
Question 5:
[0076] Observation: Regarding the question on nausea experienced during the past week, there was a notable improvement in symptoms from the screening (n=30) to day 30 (n=30). At the screening, 12 participants reported minor nausea, 10 reported mild nausea, 4 reported moderate nausea, and 2 reported moderately severe nausea. However, by day 30, the majority of participants, 21, reported no nausea at all, and only 9 reported minor nausea.
[0077] Conclusion: Nausea decreased from mild-to-moderate levels at screening to mostly no nausea by day 30.
Question 6:
[0078] Observation: Regarding the question on rumbling in the stomach experienced during the past week, the data shows a clear improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the majority of participants, 20, reported minor rumbling, 5 reported mild rumbling, and 1 reported moderate discomfort. However, by day 30, the number of participants reporting no rumbling had increased to 19, while 11 reported only minor rumbling.
[0079] Conclusion: Rumbling reduced from minor-to-mild rumbling at screening to primarily no rumbling by day 30.
Question 7:
[0080] Observation: Regarding the question on stomach bloating experienced during the past week, the data shows a notable improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the distribution of bloating severity was as follows: 11 participants reported no bloating, 10 reported mild bloating, 5 reported minor bloating, and 4 reported moderate bloating. However, by day 30, the majority of participants, 17, reported no bloating at all, and 13 reported only minor bloating.
[0081] Conclusion: Bloating improved from mild-to-moderate bloating at screening to mainly no or minor bloating by day 30.
Question 8:
[0082] Observation: Regarding the question on burping experienced during the past week, the data shows an improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the distribution of burping severity was as follows: 12 participants reported moderate burping, 11 reported no burping, 5 reported mild burping, and 2 reported minor burping. However, by day 30, the majority of participants, 15, reported no burping at all, and 13 reported only minor burping.
[0083] Conclusion: Burping reduced from moderate-to-mild levels at screening to primarily no or minor burping by day 30.
Question 9:
[0084] Observation: Regarding the question on passing gas or flatus experienced during the past week, the data shows an improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the distribution was more varied, with 9 participants reporting moderate passing of gas, 8 reporting minor passing of gas, 8 reporting no passing of gas, and 5 reporting mild passing of gas. However, by day 30, the majority of participants, 16, reported no passing of gas at all, and 14 reported only minor passing of gas.
[0085] Conclusion: Gas/flatus decreased from moderate-to-minor levels at screening to mainly no or minor gas/flatus by day 30.
Question 10:
[0086] Observation: Regarding the question on hard stools experienced during the past week, the data shows a notable improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the majority of participants, 19, reported no issues with hard stools, while 6 reported minor hard stools, 4 reported mild hard stools and 1 reported moderate symptom. By day 30, the number of participants reporting no issues with hard stools had increased to 26, and only 4 reported minor hard stools.
[0087] Conclusion: Hard stools improved from mild-to-minor hard stools at screening to predominantly no issues with hard stools by day 30.
Question 11:
[0088] Observation: Regarding the question on the sensation of not completely emptying the bowels during the past week, the data shows a marked improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, 18 participants reported minor sensations of incomplete emptying, 7 reported mild sensations, and 5 reported no such sensations. However, by day 30, the majority of participants, 27, reported no sensations of incomplete emptying, and only 3 reported minor sensations.
[0089] Conclusion: Incomplete emptying decreased from minor-to-mild sensations of incomplete emptying at screening to mostly no such sensations by day 30.
Question 12:
[0090] Observation: Regarding the question on diarrhea experienced during the past week, the data shows a notable improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the distribution was more varied, with 14 participants reporting no diarrhea, 11 reporting mild diarrhea, and 3 reporting moderate diarrhea. However, by day 30, the majority of participants, 18, reported no diarrhea at all, and 11 reported only minor diarrhea.
[0091] Conclusion: Diarrhea reduced from mild-to-moderate levels at screening to primarily no or minor diarrhea by day 30.
Question 13:
[0092] Observation: Regarding the question on loose stools experienced during the past week, the data shows a clear improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, the distribution was more varied, with 14 participants reporting minor loose stools, 8 reporting no issues with loose stools, 6 reporting mild loose stools, and 2 reporting moderate loose stools. However, by day 30, the majority of participants, 21, reported no issues with loose stools at all, and 8 reported only minor loose stools.
[0093] Conclusion: Loose stools improved from minor-to-moderate loose stools at screening to mainly no issues or only minor loose stools by day 30.
Question 14:
[0094] Observation: Regarding the question on an urgent need to have a bowel movement during the past week, the data shows a notable improvement in this symptom from the screening (n=30) to day 30 (n=30). At the screening, 14 participants reported a minor urgent need, 9 reported no urgent need, and 7 reported a mild urgent need. However, by day 30, the majority of participants, 26, reported no urgent need to have a bowel movement at all, and only 4 reported a minor urgent need.
[0095] Conclusion: Urgent bowel movements decreased from minor-to-mild urgency at screening to mostly no urgent need by day 30.
Question 15:
[0096] Observation: Regarding the question on constipation experienced during the past week, the data shows a clear improvement in this symptom from the screening (n=30) to day 30 (n=30). At the Screening, the majority of participants, 23, reported no issues with constipation, while 6 reported mild constipation and 1 reported minor constipation. By day 30, the number of participants reporting no constipation had increased to 26, and only 4 reported minor constipation.
[0097] Conclusion: Constipation improved from mild-to-minor constipation at screening to predominantly no constipation issues by day 30.
Question Screening Observations Day 30
Observations Conclusion
Pain or Discomfort 14 mild, 9 moderate, 6 moderately severe 4 mild, 19 minor, 7 resolved symptoms Reduction from moderate-to-mild levels at screening to primarily minor discomfort by day 30
Heartburn 12 moderate, 11 mild, 5 minor 7 no, 19 minor, 4 mild Decrease from moderate-to-mild levels at screening to mostly minor or no heartburn by day 30
Acid Reflux 13 minor, 6 moderately severe, 5 moderate 16 no, 12 minor Improvement from minor-to-moderate at screening to predominantly no or minor reflux by day 30
Hunger Pains 21 no, 8 minor, 1 mild All 30 no Complete resolution of symptoms, all participants reported no hunger pains by day 30
Nausea 12 minor, 10 mild, 4 moderate, 2 moderately severe 21 no, 9 minor Decrease from mild-to-moderate levels at screening to mostly no nausea by day 30
Rumbling in Stomach 20 minor, 5 mild, 1 moderate 19 no, 11 minor Reduction from minor-to-mild at screening to primarily no rumbling by day 30
Stomach Bloating 11 no, 10 mild, 5 minor, 4 moderate 17 no, 13 minor Improvement from mild-to-moderate at screening to mainly no or minor bloating by day 30
Burping 12 moderate, 11 no, 5 mild, 2 minor 15 no, 13 minor Reduction from moderate-to-mild levels at screening to primarily no or minor burping by day 30
Passing Gas (Flatus) 9 moderate, 8 minor, 8 no, 5 mild 16 no, 14 minor Decrease from moderate-to-minor levels at screening to mainly no or minor gas/flatus by day 30
Hard Stools 19 no, 6 minor, 4 mild, 1 moderate 26 no, 4 minor Improvement from mild-to-minor at screening to predominantly no issues with hard stools by day 30
Sensation of Incomplete Emptying 18 minor, 7 mild, 5 no 27 no, 3 minor Decrease from minor-to-mild sensations at screening to mostly no such sensations by day 30
Diarrhea 14 no, 11 mild, 3 moderate 18 no, 11 minor Reduction from mild-to-moderate levels at screening to primarily no or minor diarrhea by day 30
Loose Stools 14 minor, 8 no, 6 mild, 2 moderate 21 no, 8 minor Improvement from minor-to-moderate at screening to mainly no issues or only minor loose stools by day 30
Urgent Need for Bowel Movement 14 minor, 9 no, 7 mild 26 no, 4 minor Reduction from minor-to-mild urgency at screening to mostly no urgent need by day 30
Constipation 23 no, 6 mild, 1 minor 26 no, 4 minor Improvement from mild-to-minor at screening to predominantly no constipation issues by day 30
Table 7
[0098] Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based here on. Accordingly, the disclosure of the embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.
[0099] With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.
[0100] While various aspects and embodiments have been disclosed herein, other aspects and embodiment will be apparent to those skilled in the art.
, C , Claims:We Claim:
1. A nutraceutical formulation for alleviating stomach discomfort and reducing stress, the formulation comprising:
saffron (Crocus sativus) extract;
licorice (Glycyrrhiza glabra) extract;
bael (Aegle marmelos) extract;
inulin;
sodium bicarbonate;
probiotic blend;
peppermint oil extract; and
pharmaceutically acceptable excipients.
2. The formulation as claimed in claim 1, wherein the pharmaceutically acceptable excipients include:
a diluent selected from a group consisting of one of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, tricalcium phosphate Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, and Sodium starch glycolate;
a bulking agent selected from a group consisting of one of Anhydrous Lactose, Sucrose, Rice flour, Mannitol, Sorbitol, Sodium Chloride, Calcium sulphate, Kaolin, Dicalcium Phosphate, and Cellulose;
a sweetener selected from a group consisting of one of Acesulfame potassium, Saccharin, Aspartame, Sucralose, Neotame, Sorbitol, Cyclamat, Xylitol, Advantame, Alitame, Lactitol, Sugar, Erythritol, Maltitol, Mannitol, Fructose, Glucose, Glycyrrhizin, Maltose, Neohesperidin dihydrochalcone, Stevioside, Tagatose, and Thaumatin;
an humectant selected from a group consisting of one of Xylitol, sodium malate, sodium lactate, sorbitol;
a stabilizer selected from a group consisting of one of PVP (Povidone), PVA (Polyvinyl alcohol), PEG (Polyethylene glycol), HPMC (Hypromellose), HPC (Hydroxypropyl cellulose), HEC (Hydroxyethyl cellulose), NaCMC (Carboxymethylcellulose sodium), SD (Docusate sodium), SLS (Sodium lauryl sulfate), PEI (Polyethylene imine), TPGS (D-α-tocopheryl polyethylene glycol succinate), PEO (Polyethylene oxide), and PPO (Polypropylene oxide);
an acidity regulator selected from a group consisting of one of Sodium salts, Sorbic acid, Acetic acid, Benzoic acid, Citric acid, and Propionic acid;
a flavor enhancer selected from a group consisting of one of Vanillin, Ethyl vanillin, Maltol, Ethyl maltol, or any naturally derived flavor;
an anti-caking agent selected from a group consisting of one of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Silicon dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, and Yellow prussiate of soda.
3. The formulation as claimed in claim 1, wherein the formulation comprises:
the saffron extract in an amount of 0.50% to 1.50% by weight;
the licorice extract in an amount of 3.00% to 6.00% by weight;
the bael extract in an amount of 5.00% to 10.00% by weight;
the inulin in an amount of 15.00% to 25.00% by weight;
the sodium bicarbonate in an amount of 1.00% to 2.00% by weight;
the probiotic blend in an amount of 2.00% to 4.00% by weight; and
the peppermint oil extract as balance amount.
4. The formulation as claimed in claim 3, wherein the wherein the probiotic blend includes Lactobacillus acidophilus, Lactobacillus paracasei, and Bifidobacterium lactis.
5. The formulation as claimed in claim 2, wherein the pharmaceutically acceptable excipients comprise:
the diluent in an amount ranging from 1.5% to 3.5% by weight;
the bulking agent in an amount ranging from 10% to 20% by weight;
the sweetener in an amount ranging from 0.1% to 1.0% by weight;
the humectant in an amount ranging from 25% to 40% by weight;
the stabilizer in an amount ranging from 1% to 2% by weight;
the acidity regulator in an amount ranging from 2% to 3% by weight;
the flavor enhancer in an amount ranging from 4% to 5% by weight; and
the anti-caking agent in an amount ranging from 0.5% to 1% by weight.