Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of nutraceutical formulations. More particularly, the present invention pertains to a formulation designed to manage stress and improve mental well-being.
BACKGROUND
[0002] Stress is an inevitable part of life, arising from the demands of work, personal relationships, financial pressures, or even unexpected events. While moderate stress can sometimes be motivating, chronic stress can have detrimental effects on physical and mental health. Achieving and maintaining a state of calmness in the face of stress is crucial for overall well-being, but it is a challenge many people struggle to overcome. In today’s fast-paced world, individuals are often juggling multiple responsibilities, leaving little time for relaxation. The constant bombardment of information through technology and social media adds to the mental load, making it harder to disconnect and unwind. Stress activates the body’s “fight or flight” response, releasing hormones like adrenaline and cortisol. While this response is beneficial in short-term danger, prolonged activation can lead to fatigue, anxiety, and other health problems. Further, chronic stress is linked to cardiovascular diseases, weakened immunity, and digestive issues. Persistent stress can lead to anxiety, depression, and burnout. Stress often manifests as irritability or withdrawal, straining personal and professional relationships. Additionally, stress reduces concentration and efficiency, leading to decreased performance and job dissatisfaction.
[0003] Mental health illnesses affect a significant portion of the global population, with statistics indicating that 1 in every 5 individuals experiences symptoms at some point in their lives. Half of these conditions emerge by age 14, and three-quarters develop by age 24. Currently, approximately 970 million people worldwide struggle with mental illness, highlighting the pressing need for effective interventions (as per survey conducted in 2023). Mental disorders contribute significantly to global mortality rates, accounting for 14.3% of deaths annually, or approximately 8 million deaths. This underscores the importance of developing accessible and efficient solutions for managing mental health conditions.
[0004] Various prior arts have explored different compositions and applications of herbal and probiotic formulations aimed at manage stress and promote a state of calmness. For instance, in a patent literature, US11524043B2 discloses a therapeutic composition for addressing physiological stresses and aging include an immune modulator and one or more adaptogenic nutrients. Some non-limiting examples of immune modulators include as transfer factor, low molecular weight fraction immune modulators and/or other low molecular weight fractions of colostrum, egg or any other source of transfer factor or low molecular weight fraction immune modulators. Methods for administering immune modulators and adaptogenic nutrients to a subject to address the effects of physiological stresses and aging in the body of the subject, such as inflammatory responses, are also disclosed.
[0005] In another patent literature, US20070036873A1 discloses a method of treatment or management of various adaptogenic conditions, such as, stress in mammals, more particularly, humans, comprising administering Withania somnifera plant extract. A high purity extract composition comprising withanolide glycosides, oligosaccharides, withanolide aglycones and a minimum level of polysaccharides, and a pharmaceutically, veterinary or nutritionally acceptable carrier(s) is disclosed. Preferably, the composition of the said invention can be devoid of any alkaloids or contains trace levels of alkaloids. The method of treatment or management of stress administering the composition comprising Withania somnifera of the said invention does not suffer from any one of the abovementioned side effects even after prolonged use. The disclosure also illustrates a method of preconditioning a mammalian patient to improve the patient's resistance and reaction to subsequently encountered stress.
[0006] In another patent literature, US20060286183A1 describes compositions and methods for administering to the diet of humans a composition for inducing rapid weight loss, controlling appetite, managing stress and supporting mental well-being, supporting relaxation, and combating fatigue. A diet supplement comprising Calcium and Potassium double salt of Garcinia Cambogia Extract supplying 60% Hydroxycitric Acid, Gymnema Sylvestre Leaf Extract, Rhodiola Rosea Root Extract, Theanine, Astaxanthin Algae Extract, Chromium Polynicotinate, Hoodia Gordonii, N-olyl-phosphatidyl ethanolamine (NOPE)/EGCG blend, Vinpocetine, Russian Tarragon Extract, N-acetyl tyrosine, and Withania Somnifera Root Extract is provided. Said diet supplement is comprised of at least Hoodia Gordonii wherein the extract does not contain any extract from the root of the plant.
[0007] Further, another patent literature US20120328663A1 presents compositions including combinations of β-glucan and Withania somnifera for increasing the immune activity of certain target cytokines and phagocytosis, and reducing cortisol or corticosterone. Methods of improving immunity activity under periods of stress including chronic stress with a combination of β-glucan and Withania somnifera are also described. Particular combinations of β-glucan and Withania somnifera synergistically increases the immune activity of the cytokines IL-12 and IL-6 over expected values.
[0008] Another patent literature US20060172021A1 discloses herbal compositions useful for the prevention or treatment of the symptoms of stress and/or infection in a subject in need thereof. The herb-containing compositions of the invention can be formulated in a dry delivery system, liquid delivery system, or a controlled-release vehicle. The herb-containing compositions of the invention are formulated as dosage unit forms which include a tablet; dry powder; capsule; and caplet. The said invention also provides methods for the prevention, alleviation or treatment of symptoms of stress or infection in a subject.
[0009] Furthermore, another patent literature US20190117717A1 discloses a herbo-mineral formulation for the treatment of Cardio vascular diseases and method of preparing the same. The disclosed herbo-mineral formulation includes herb and mineral components which facilitate in treating Cardio vascular diseases. Cardio vascular diseases may include any condition associated with heart and blood vessels. Further, the disclosed formulation may also be instrumental as anti-oxidating, anti-stress, hypolipidemic, atherogenic, antihypertensive, apoptotsis inhibiting and cardio-protective agent.
[0010] Additionally, in another patent literature, WO2022256624A1 discloses compositions used and methods for regulation of homeostasis of host cortisol and improving sleep quality including a composition derived from enriched for one or more phenylpropanoid acids and benzoxazinoids or extracts that are enriched for one or more phenylpropanoid acids and benzoxazinoids. Compositions of enriched for one or more phenylpropanoid acids and benzoxazinoids maintain homeostasis of host stress hormone, cortisol, selectively binds to MT2 over MT1 receptor, improves sleep quality by enhancing the deep sleep stage of sleep, increases total sleep time and deep sleep time, improves overall mental well-being measured by the Pittsburgh Sleep Quality Index (PSQI) and Profile of Mood States (POMS), provides positive mood support and enhances emotional well-being; maintains homeostasis of biomarkers - serotonin, melatonin, GABA in formulation in a mammal disclosed that includes administering an effective amount of a composition from 0.01 mg/kg to 1000 mg/kg body weight of the mammal.
[0011] Also, another patent literature, WO2006061849B1 discloses an herbal composition, which promotes the proven pharmacological activities such as anti-oxidant, anti-stress and adaptogenic activities. Composition(s) comprises of plant juices or extracts together with the conventional recipients to form a paste/jelly/jam/cake/cream puff/chocolate forms, fortified with plants like Mangifera indica, Evolvulus alsinoides, Withania somnifera and Asparagus recemosus Amaranthus hypochondriacus etc., which are used as functional foods.
[0012] Further, another patent literature, WO2020162859A2 discloses a supplemental product developed for the treatment of somatoform disorders such as vegetative-vascular dystonia, for reducing stress in adults, for the treatment of psychological disorders such as depression and anxiety and for the treatment of menopause disorders, premenstrual syndrome and migraine, wherein it discloses a combination and production method thereof, containing passiflora (passiflora incarnata) in the ratio of 10% - 30% by weight, glycine in the ratio of 1%-30% by weight, L-methyfolate (folic acid) in the ratio of 0.008%-25% by weight, magnesium L-threonate in the ratio of 2%-41% by weight.
[0013] While these prior arts contribute significantly to their respective fields, but the existing technologies are devoid of ensuring a synergistic effect for managing stress and promoting relaxation. Therefore, in order to avoid such problems, there is a need for a novel and advanced nutraceutical formulation that addresses stress reduction and also significantly promotes a state of calmness and relaxation. The present disclosure is directed to overcome one or more limitations stated above, and any other limitation associated with the prior arts.
SUMMARY
[0014] 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.
[0015] The present invention is directed to a nutraceutical formulation for reducing stress and promoting calmness. The formulation comprises ashwagandha root (Withania somnifera(L.) Dunal) extract; saffron (Crocus sativus) extract; lavender (Lavandula angustifolia) extract; and pharmaceutically acceptable excipients. In one embodiment, the pharmaceutically acceptable excipients include a bulking agent, a sweetener, a flavor enhancer, a stabilizer, an acidity regulator, a diluent, a coloring agent, a gelling agent, a thickener agent, and an anti-sticking agent.
[0016] 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.
DETAILED DESCRIPTION
[0017] 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.
[0018] 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.
[0019] 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.
[0020] The present invention relates to a nutraceutical formulation designed to reduce stress and promote relaxation, particularly in individuals experiencing high levels of physiological stress and mental fatigue. This innovative formulation incorporates a synergistic blend of active ingredients, including Withania somnifera (Ashwagandha), Crocus sativus (Saffron) and Lavandula Angustifolia, alongside various inactive ingredients that enhance the overall efficacy and stability of the product. The primary objective of this invention is to offer a natural, safe, and effective means to manage stress and promote a state of calmness without the adverse side effects commonly associated with pharmaceutical alternatives.
[0021] Also, the object of the present invention is to reduce cortisol levels through the use of Withania somnifera extract, which helps mitigate the physiological impact of stress. By incorporating Crocus sativus extract, the formulation seeks to alleviate anxiety and elevate mood naturally, offering an alternative to pharmaceutical treatments. Additionally, Lavandula angustifolia extract is included to calm the mind and reduce brain hyperactivity, promoting relaxation and mental clarity. The nutraceutical formulation is further prepared in the form of oral formulation, this ensures convenient and pleasant consumption, enhancing user compliance. The use of natural, safe ingredients ensures that the formulation is non-toxic and free from harmful additives, providing health benefits without adverse effects. Therefore, the objective of the present invention is to offer a holistic, natural solution for stress management and mental well-being, supported by clinically proven dosages and methods.
[0022] 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.
[0023] The nutraceutical formulation comprises Withania somnifera (Ashwagandha) extract, Crocus sativus (Saffron) extract, and Lavandula angustifolia (Lavender) extract. Each ingredient plays a crucial role in reducing stress and promoting calmness. Ashwagandha extract helps balance cortisol levels, reducing the physiological effects of stress. Saffron extract has been shown to alleviate anxiety and elevate mood, offering a natural alternative to pharmaceutical treatments. Lavender extract calms the mind and reduces brain hyperactivity, promoting relaxation and mental clarity.
[0024] What sets the proposed nutraceutical formulation apart is its unique blend of natural extracts, carefully selected for their stress-reducing and calming properties. Unlike traditional pharmaceutical interventions, which often come with side effects, the proposed formulation provides a natural and holistic approach to managing stress and promoting mental well-being. By combining these ingredients in precise proportions, the formulation offers a convenient and effective solution for individuals seeking to reduce stress and enhance calmness.
[0025] The formulation is obtained through a meticulous process that ensures the preservation of the active ingredients' potency and efficacy. The extracts are carefully sourced and processed to retain their natural properties. The ingredients are then combined in specific ratios to achieve the desired effects. The final product is a nutraceutical formulation in the form of gummies, making it easy and enjoyable to consume.
[0026] In one embodiment of the invention, the nutraceutical formulation disclosed in this invention is designed to reduce stress and promote calmness. It combines three key ingredients: Withania somnifera (Ashwagandha) extract, Crocus sativus (Saffron) extract, and Lavandula angustifolia (Lavender) extract. Each ingredient plays a crucial role in stress management and mental health nurturing.
[0027] Ashwagandha (Withania somnifera) helps in balancing cortisol levels, reducing stress and anxiety. It also enhances overall well-being and improves resilience to stress. Ashwagandha acts as an adaptogen, helping the body manage stress more effectively. Ashwagandha reduces cortisol levels, which in turn reduces the physiological effects of stress. Saffron contains compounds that increase serotonin levels in the brain, which can improve mood and reduce symptoms of anxiety and depression. Lavender has a calming effect on the nervous system, helping to reduce anxiety, stress, and insomnia.
[0028] Saffron (Crocus sativus) is known for its mood-enhancing properties. Saffron helps alleviate symptoms of anxiety and depression, promoting a sense of calmness and well-being. Crocus sativus, commonly known as saffron, reduces stress through multiple mechanisms in the human body. The active compounds in saffron, such as crocin, safranal, and picrocrocin, inhibit the reuptake of serotonin, thereby increasing serotonin levels in the brain, which enhances mood and promotes a sense of well-being. Additionally, saffron modulates dopamine and norepinephrine levels, further contributing to emotional balance. Saffron’s strong antioxidant properties help neutralize reactive oxygen species (ROS) and reduce oxidative stress, while its anti-inflammatory effects lower the production of pro-inflammatory cytokines. Saffron also regulates the hypothalamic-pituitary-adrenal (HPA) axis, leading to reduced cortisol levels, the primary stress hormone. Furthermore, saffron promotes neurogenesis and protects neurons, supporting cognitive function and emotional stability. By interacting with the GABA system, saffron enhances GABA activity, which calms the nervous system and reduces anxiety. Clinical studies have demonstrated saffron's efficacy in decreasing symptoms of anxiety and depression, making it a safe and effective natural remedy for stress reduction.
[0029] Lavender (Lavandula angustifolia) has calming and relaxing effects on the nervous system. Lavender helps in reducing restlessness, anxiety, and insomnia, promoting better sleep and overall mental health. Lavandula angustifolia, commonly known as lavender, reduces stress and increases calmness through several mechanisms in the human body. The primary active compounds in lavender, such as linalool and linalyl acetate, interact with the central nervous system by modulating the activity of neurotransmitters, particularly GABA (gamma-aminobutyric acid). By enhancing GABA transmission, lavender promotes relaxation and reduces anxiety. Additionally, these compounds inhibit the release of cortisol, the stress hormone, thereby lowering stress levels. Lavender also has anti-inflammatory and antioxidant properties, which help mitigate the physical effects of stress on the body. Aromatherapy with lavender essential oil has been shown to reduce heart rate and blood pressure, further contributing to a state of calm. Through these combined effects, lavender effectively promotes a sense of calmness and well-being.
[0030] 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, acidity regulator, gelling agent, thickener agent, anti-sticking agent, flavour enhancer different functional groups enhancing the taste, stability and effectiveness of the formulation as excipients.
[0031] In one embodiment, the bulking agent is selected from a group consisting of one of Anhydrous Lactose, Sucrose, Rice flour, Maltitol, Sorbitol, Sodium Chloride, Calcium sulphate, Kaolin, Dicalcium Phosphate, and Cellulose. The sweetener is selected from a group consisting of one Acesulfame potassium, Saccharin, Aspartame, Sucralose, Neotame, Sorbitol, Cyclamat, Xylitol, Advantame, Alitame, Lactitol, Sugar, Erythritol, Maltitol, Mannitol, Fructose, Glucose, Glycyrrhizin, Maltose, Neohesperidin dihydrochalcone, Steviol Glycoside, Tagatose, Tagatose, or Thaumatin.
[0032] The flavor enhancer is selected from a group consisting of one of Vanillin, Ethyl vanillin, Maltol, Ethyl maltol, or any naturally derived flavor. The stabilizer is selected from a group consisting of one of Trisodium citrate, 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), Tapioca starch, TPGS (D-α-tocopheryl polyethylene glycol succinate), PEO (Polyethylene oxide), and PPO (Polypropylene oxide). The acidity regulator is selected from a group consisting of one of Trisodium Citrate, Sorbic acid, Acetic acid, Benzoic acid, Citric acid, and Propionic acid.
[0033] The diluent is selected from a group consisting of one of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, purified water, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, Sodium starch glycolate. The coloring agent is selected from natural colors. The gelling agent is selected from a group of Pectin, Furcellaran, Sodium alginate, Potassium chloride and Gellan gum. The thickener agent is selected from a group of Tapioca starch, Furcellaran, Oxidized starch and xylitol. The anti-sticking agent is selected from a group consisting of corn starch, carnauba wax, beeswax, and sunflower oil.
[0034] The source and geographical origin of the aforesaid component is as listed below as in Table 1.
Ingredient Scientific Name Part Used Geographical Origin
Ashwagandha Withania somnifera Root Extract India
Saffron Crocus sativus Extract France
Lavender Lavandula angustifolia Extract India
Table 1
[0035] In one embodiment, the present invention discloses a synergistic composition comprising herbal extracts of:
1. the ashwagandha root extract in an amount of 1% to 5% by weight;
2. the saffron extract in an amount of 0.01% to 2% by weight;
3. the lavender extract in an amount of 0.5% to 3% by weight; and
4. the pharmaceutically acceptable excipients as balance amount.
[0036] Further, the pharmaceutical acceptable excipients used in the present invention are:
1. the bulking agent in an amount ranging from 40% to 60% by weight;
2. the sweetener in an amount ranging from 1.0% to 2.5% by weight;
3. the flavor enhancer in an amount ranging from 0.1% to 0.1% by weight;
4. the stabilizer in an amount ranging from 0.5% to 1.5% by weight;
5. the acidity regulator in an amount ranging from 3.5% to 4.5% by weight;
6. the diluent in an amount ranging from 0.1% to 1% by weight;
7. the coloring agent in an amount ranging from 0.1% to 1% by weight;
8. The gelling agent in an amount ranging from 2.5% to 5.0% by weight;
9. The thickener agent in an amount ranging from 2.5% to 5.0% by weight; and
10. The anti-sticking agent in an amount ranging from 0.1 % to 1 % by weight.
[0037] In an exemplary embodiment, the synergistic composition comprises herbal extracts of:
1. the ashwagandha root extract in an amount of 2.0 % by weight;
2. the saffron extract in an amount of 0.24 % by weight;
3. the lavender extract in an amount of 0.80 % by weight; and
4. the pharmaceutically acceptable excipients as balance amount.
[0038] In the exemplary embodiment, the pharmaceutical acceptable excipients used in the present invention are:
1. the bulking agent in an amount ranging from 55% by weight;
2. the sweetener in an amount ranging from 0.6% by weight;
3. the flavor enhancer in an amount ranging from 1% by weight;
4. the stabilizer in an amount ranging from 1% by weight;
5. the acidity regulator in an amount ranging from 5% by weight;
6. the diluent in an amount ranging from 25.66% by weight;
7. the coloring agent in an amount ranging from 0.5% by weight;
8. The gelling agent in an amount ranging from 3.50% by weight;
9. The thickener agent in an amount ranging from 2.5% by weight; and
10. The anti-sticking agent in an amount ranging from 1 % by weight.
[0039] Accordingly, in another exemplary embodiment, the present invention discloses a synergistic composition comprising herbal extracts of:
1. the ashwagandha root extract in an amount of 100 mg to 200 mg by weight;
2. the saffron extract in an amount of 10 mg to 50 mg by weight;
3. the lavender extract in an amount of 25 mg to 75 mg by weight; and
4. the pharmaceutically acceptable excipients as balance amount.
[0040] In another exemplary embodiment, the present invention discloses a synergistic composition comprising herbal extracts of;
1. the ashwagandha root extract in an amount of 125 mg by weight;
2. the saffron extract in an amount of 15 mg by weight;
3. the lavender extract in an amount of 50 mg by weight; and
4. the pharmaceutically acceptable excipients as balance amount.
[0041] Together, these ingredients work synergistically to provide a natural and effective way to reduce stress and promote calmness, offering a convenient and enjoyable supplement option for individuals seeking to improve their mental well-being.
[0042] The nutraceutical formulation described in this invention offers a natural and effective solution for managing stress and promoting mental well-being. By combining Ashwagandha, Saffron, and Lavender extracts in precise proportions, the formulation provides a holistic approach to stress management, helping individuals achieve a sense of calmness and balance in their lives.
[0043] In one embodiment, the proposed invention illustrates a method of preparing a nutraceutical formulation for reducing stress and promoting calmness. The method comprises the steps of adding gelling agent and powdered sweetener into distiller water and heating up to 900ºC - 950ºC. The method further comprises, upon having the gelling agent and the sweetener completely dissolved into the distilled water, adding bulking agent into the mixture and simmering the mixture till the bulking agent is completely dissolved. The method includes adding ashwagandha root extract, saffron extract, lavender extract, coloring agent, flavor enhancer into the mixture, upon cooling the mixture to 800ºC, and transferring the mixture into a set of moulds at 700ºC. The method comprises demolding gummies upon solidification and drying of the mixture in the moulds, and spraying anti-sticking agent over the gummies and packing the gummies.
Experimental and Clinical Trial Details:
[0044] A study was conducted on individuals experiencing mild to moderate stress, aged between 18 to 45 years (both inclusive), to assess the compliance, clinical, vital parameter assessment, and tolerability of the formulation. The trial was an open-label, single-arm, safety study, with each subject receiving the formulation two serving of 4.7 grams daily after a meal. 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 CBC, LFT, and RFT parameters, as well as clinical, vital parameters, tolerability, perceived stress by perceived stress scale (PSS) score questionnaire, and alertness, memory, and perceived energy throughout a self-reported Linkert scale. Adverse events were also monitored throughout the study period.
[0045] 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 conducted in accordance with the approved protocol and ICH-Good Clinical Practices (GCP) guidelines.
[0046] The study adhered strictly to ICH-GCP guidelines, ensuring the rights, safety, and well-being of participants were of utmost importance throughout the trial. Investigational products were prepared in accordance with Good Manufacturing Practices (GMP) standards applicable in India.
[0047] Prior to participation, voluntary written informed consent was obtained from all subjects. The informed consent process provided a comprehensive explanation of the study's objectives, design, risks, and benefits. For illiterate subjects, an impartial witness read and explained the Informed Consent Form (ICF) in the subject's preferred language. Thumb impressions from illiterate subjects and signatures from impartial witnesses were obtained on the ICF. Subject identities were kept confidential, and study data was coded to maintain privacy. The results of the study may be published in peer-reviewed scientific journals with the consent of the investigators, without revealing subject identities.
[0048] 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.
[0049] Inclusion Criteria:
1. Healthy male and female individuals aged between 18 to 45 years (both inclusive).
2. Participants required to have scored between 7 and 26 on the Perceived Stress Scale (PSS) and reported perceived impacts on alertness, memory, and energy levels.
3. Participants not consuming anti-depressants /anti-anxiety/ mood enhancing/recreational drugs intake for at least one year at the start of the screening visit.
[0050] 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 taking any medicine or dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
Result of the Study:
[0051] Demographic characteristics – All thirty participants (22 males and 08 females) successfully completed the study. The average age of the subjects was 35.67 ± 7.24 years. Male participants had an average weight of 57.95 kg, a height of 165.59 cm, and a BMI of 21.21 kg/m². Female participants had an average weight of 45.88 kg, a height of 156.25 cm, and a BMI of 18.97 kg/m². These demographic details are summarized in Table 2.
Demographic Details Male (Mean ± SD) (n=22) Female (Mean ± SD) (n=8) P Value
Average Age (Years) 34.5 ± 7.13 38.88 ± 6.96 0.146
Anthropometric Parameters
Height (cm) 165.59 ± 8.08 156.25 ± 8.12 0.009*
Weight (kg) 57.95 ± 14.70 45.88 ± 9.08 0.039*
BMI (kg/m2) 21.21 ± 5.34 18.97 ± 4.56 0.306
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.
[0052] Assessment of hematological and biochemical investigations – The analysis of the hematological and biochemical parameters showed no statistically as well as clinically significant changes between the screening and day 30 time points, with the exception of a slight increase in mean corpuscular hemoglobin concentration (MCHC) (p=0.001). All other blood parameters, including white and red blood cell counts, hemoglobin, liver function tests, and kidney function tests, remained stable and within the respective reference ranges throughout the study period. These findings indicate the study intervention did not have any clinically relevant impact on the participants' overall blood profile during the 30-day evaluation as illustrated in Table 3.
Parameters Screening (Mean ± SD) Day 30 (Mean ± SD) p-Value Reference Range
Hematological Parameters
White Blood Cell Count 7356.67 ± 1295.80 cells/cu.mm 7210.00 ± 1803.70 cells/cu.mm 0.732 4000-11000 cells/cu.mm
Red Blood Cell Count 5.07 ± 0.77 mil/cu.mm 4.94 ± 0.68 mil/cu.mm 0.431 4.7 - 6.0 mil/cu.mm
Hemoglobin 14.03 ± 1.59 gm/dL 13.82 ± 1.64 gm/dL 0.264 Female: 11.6-15 gm/dL, Male: 13.2-16.6 gm/dL
Hematocrit (PCV) 43.02 ± 4.87 % 41.03 ± 6.67 % 0.091 42 - 52 %
Mean Corpuscular Volume (MCV) 84.97 ± 10.65 fL 86.45 ± 8.38 fL 0.563 78 - 100 fL
Mean Corpuscular Hemoglobin (MCH) 27.89 ± 3.81 pg 28.19 ± 3.96 pg 0.784 27 - 31 pg
Mean Corpuscular Hemoglobin Concentration (MCHC) 32.62 ± 0.83 gm/dL 33.18 ± 0.75 gm/dL 0.001* 32-36 gm/dL
Platelet Count 310.33 ± 71.99 x 10^3/uL 309.60 ± 64.57 x 10^3/uL 0.952 150-450 x 10^3/uL
Differential WBC
Neutrophils 60.47 ± 6.36 % 58.87 ± 7.28 % 0.223 40 - 75 %
Lymphocytes 32.00 ± 5.92 % 32.33 ± 4.54 % 0.75 20 - 40 %
Monocytes 4.43 ± 1.85 % 4.20 ± 1.27 % 0.234 2-10 %
Eosinophils 3.10 ± 0.88 % 3.40 ± 0.97 % 0.078 1-6 %
Basophils 0.00 ± 0.00 % 0.00 ± 0.00 % 1 0-1 %

Parameter Screening (Mean ± SD) Day 30 (Mean ± SD) p-Value Reference Range
Total Protein 7.69 ± 0.61 g/dL 7.72 ± 0.63 g/dL 0.784 6.0 - 8.3 g/dL
Albumin 4.44 ± 0.26 g/dL 4.50 ± 0.33 g/dL 0.313 3.2 - 5.5 g/dL
Globulin 3.25 ± 0.54 g/dL 3.22 ± 0.50 g/dL 0.729 1.8 - 3.6 g/dL
A/G Ratio 1.40 ± 0.22 1.43 ± 0.24 0.375 1.2 - 2.2
Bilirubin
Total Bilirubin 0.78 ± 0.42 mg/dL 0.73 ± 0.36 mg/dL 0.267 0.1-1.2 mg/dL
Direct Bilirubin 0.32 ± 0.20 mg/dL 0.28 ± 0.10 mg/dL 0.157 0-0.4 mg/dL
Indirect Bilirubin 0.46 ± 0.28 mg/dL 0.45 ± 0.30 mg/dL 0.701 0.1-0.8 mg/dL
Enzymes
Aspartate Transaminase (AST) 33.21 ± 10.37 U/L 32.63 ± 7.96 U/L 0.693 49 U/ L
Alanine Transaminase (ALT) 27.65 ± 8.46 U/L 28.04 ± 8.24 U/L 0.697 49 U/ L
Alkaline Phosphatase (ALP) 140.00 ± 30.41 U/L 138.48 ± 30.78 U/L 0.761 80 - 306 U/ L
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.
[0053] Assessment of vital signs – There were no significant differences in systolic blood pressure, diastolic blood pressure, heart rate, body temperature, or respiratory rate between the two study visits. These findings indicate the study intervention did not have any clinically relevant impact on the participants' vital sign parameters over the 30-day evaluation period as demonstrated in, as indicated in Table 4.
Parameter Screening Day 30 p-Value
Systolic Blood Pressure (mmHg) 120.33 ± 10.58 117.33 ± 9.72 0.267
Diastolic Blood Pressure (mmHg) 76.67 ± 6.24 74.63 ± 6.89 0.173
Heart Rate (beats per minute) 76.40 ± 8.21 76.97 ± 11.85 0.832
Body Temperature (°F) 97.02 ± 1.19 96.33 ± 1.83 0.063
Respiratory Rate (breaths per minute) 19.97 ± 1.19 19.77 ± 1.33 0.447
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.
[0054] Assessment of adverse events – The adverse events observed during the study are presented in Table 5. Out of the 30 participants, a total of 3 subjects (10%) experienced at least one adverse event. The most commonly reported adverse events were fever and headache. For each adverse event, the number of subjects affected and the corresponding rescue medication used are shown. AE’s observed were not related to investigational product.
Adverse Event No. of subjects(N=30) Rescue Medication
Fever 1 Paracetamol
Headache 2 Aspirin
Total 03(10%) -
Table 5
[0055] Assessment of perceived stress using perceived stress scale – The PSS is a ten-question questionnaire with responses from 0 to 4, measuring an individual's stress perception. The total score is the sum of all responses, indicating the perceived stress level. Scores: 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress). [053] The assessment of perceived stress using the PSS demonstrated a statistically significant decrease from the screening visit to the end of the study on day 30 by 45.45 % as presented in Table 6. The observed change in PSS score was statistically highly significant, suggesting a clinically meaningful improvement in the participant's subjective experience of stress.
Parameter Screening Day 30 p-Value % Change
PSS Score 24.20 ± 1.40 13.20 ± 1.81 <0.001* 45.45%
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.
[0056] Assessment of alertness, memory, and perceived energy by 4-point Linkert Scale - The subjects' self-reported assessments of alertness, memory, and perceived energy were evaluated using a 4-point Likert scale as follows: 0-worsened; 1-not improved; 2-improved; 3-improved significantly at screening and on day 30. The results showed statistically significant improvements in all three parameters from screening to the end of the study period.
[0057] At the screening, 26 subjects reported a score of worsened for alertness, 4 subjects reported a score of not improved. All participants (100%) exhibited an improved alertness after 30 days of treatment.
[0058] Similarly, at screening 27 subjects reported worsened memory. All participants (100%) showed an improved memory after 30 days of treatment. Furthermore, 27 subjects reported worsened perceived energy levels. All participants (100%) reported an increased perceived energy levels after 30 days of treatment. Data is demonstrated in Table 7.
Parameter Score Screening Day 30
Alertness 0 26 0
1 4 0
2 0 23
3 0 7
Memory 0 27 0
1 3 3
2 0 22
3 0 8
Perceived Energy 0 27 0
1 3 3
2 0 22
3 0 8
Table 7
[0059] 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.
[0060] 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.
[0061] While various aspects and embodiments have been disclosed herein, other aspects and embodiment will be apparent to those skilled in the art.

, Claims:We Claim:
1. A nutraceutical formulation for reducing stress and promoting calmness, the formulation comprising:
Ashwagandha root (Withania somnifera (L.) Dunal) extract;
Saffron (Crocus sativus) extract;
Lavender (Lavandula angustifolia) extract; and
pharmaceutically acceptable excipients.
2. The formulation as claimed in claim 1, wherein the pharmaceutically acceptable excipients include:
a bulking agent selected from a group consisting of one of Anhydrous Lactose, Sucrose, Rice flour, Maltitol syrup, 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, Steviol glycoside, Tagatose, or Thaumatin;
a flavor enhancer selected from a group consisting of one of Vanillin, Ethyl vanillin, Maltol, Ethyl maltol, or any naturally derived flavor;
a stabilizer selected from a group consisting of one of Trisodium citrate, 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), Tapioca starch, 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 Trisodium Citrate, Sorbic acid, Acetic acid, Benzoic acid, Citric acid, or Propionic acid;
a diluent selected from a group consisting of one of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, purified water, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, Sodium starch glycolate;
a coloring agent selected from natural colors;
a gelling agent selected from a group of Pectin, Furcellaran, Sodium alginate, Potassium chloride and Gellan gum;
a thickener agent selected from a group of Tapioca starch, Furcellaran, Oxidized starch and xylitol; and
an anti-sticking agent selected from a group consisting of corn starch, carnauba wax, beeswax, and sunflower oil.
3. The formulation as claimed in claim 1, wherein the formulation comprises:
the ashwagandha root extract in an amount of 1% to 5% by weight;
the saffron extract in an amount of 0.01% to 2% by weight;
the lavender extract in an amount of 0.5% to 3% by weight; and
the pharmaceutically acceptable excipients as balance amount.
4. The formulation as claimed in claim 2, wherein the pharmaceutically acceptable excipients comprise:
the bulking agent in an amount ranging from 40% to 60% by weight;
the sweetener in an amount ranging from 1.0% to 2.5% by weight;
the flavor enhancer in an amount ranging from 0.1% to 0.1% by weight;
the stabilizer in an amount ranging from 0.5% to 1.5% by weight;
the acidity regulator in an amount ranging from 3.5% to 4.5% by weight;
the diluent in an amount ranging from 0.1% to 1% by weight;
the coloring agent in an amount ranging from 0.1% to 1% by weight;
the gelling agent in an amount ranging from 2.5% to 5.0% by weight;
the thickener agent in an amount ranging from 2.5% to 5.0% by weight; and
the anti-sticking agent in an amount ranging from 0.1 % to 1 % by weight.
5. A method of preparing a nutraceutical formulation for reducing stress and promoting calmness, the method comprises:
adding gelling agent and powdered sweetener into distiller water and heating up to 900ºC - 950ºC;
upon having the gelling agent and the sweetener completely dissolved into the distilled water, adding bulking agent into the mixture and simmering the mixture till the bulking agent is completely dissolved;
upon cooling the mixture to 800ºC, adding ashwagandha root extract, saffron extract, lavender extract, coloring agent, flavor enhancer into the mixture;
transferring the mixture into a set of moulds at 700ºC;
demolding gummies upon solidification and drying of the mixture in the moulds; and
spraying anti-sticking agent over the gummies and packing the gummies.
6. The method as claimed in claim 5, wherein the gelling agent is selected from a group of Pectin, Furcellaran, Sodium alginate, Potassium chloride and Gellan gum.
7. The method as claimed in claim 5, wherein 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, Steviol glycoside, Tagatose, or Thaumatin.
8. The method as claimed in claim 5, wherein the bulking agent is selected from a group consisting of one of Anhydrous Lactose, Sucrose, Rice flour, Maltitol syrup, Sorbitol, Sodium Chloride, Calcium sulphate, Kaolin, Dicalcium Phosphate, and Cellulose.
9. The method as claimed in claim 5, wherein an anti-sticking agent is selected from a group consisting of corn starch, carnauba wax, beeswax, and sunflower oil.