Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of nutraceutical formulations. More particularly, the present invention pertains to a dietary supplement formulation for reducing stress and boosting testosterone production and stamina.
BACKGROUND
[0002] Modern lifestyles often come with high stress, sedentary habits, and irregular routines, which can significantly impact testosterone production and stamina. Testosterone, a key hormone for energy, muscle growth, and mood, is sensitive to both physical and psychological stressors. Some of the key issues that affect testosterone levels and stamina in today’s fast-paced life includes chronic stress, poor sleep quality, sedentary lifestyle, unhealthy diet and nutritional deficiencies, exposure to endocrine disruptors etc.
[0003] Various prior arts have explored different compositions and applications of herbal and nutraceutical formulations aimed at improving performance, reducing stress, and enhancing overall well-being. For instance, in a patent literature CN109276539A discloses a testosterone gel. The testosterone gel is prepared from the following components in parts by weight: 0.02-0.40 part of testosterone, 0.5-2 parts of carbomer and 0.5-3.5 parts of an L40 transdermal agent or S6 transdermal agent or azone. The L40 transdermal agent is prepared from a caulis spatholobi extract and a saffron extract. By adding the L40 transdermal agent or the S6 transdermal agent or the azone into the testosterone and the carbomer, the transdermal effect can be effectively improved, absorption can be promoted, and the therapeutic effect can be improved. However, the proposed composition focuses on testosterone delivery and transdermal applications rather than performance enhancement or stress reduction.
[0004] In another patent literature, US20170028012A1 describes an herbal dietary supplement for increasing the testosterone level, libido, and sexual performance of a human. The herbal dietary supplement also increases the energy level of a human. The herbal dietary supplement may be prepared and provided in the forms of a liquid beverage or food bar for oral consumption. In such forms, the herbal dietary supplement comprises Ashwagandha and Mucuna Pruriens. Other ingredients may be included to further increase a human's testosterone level, libido, and/or energy level or to customize and/or enhance the effects of the other ingredients in the herbal dietary supplement. Such other ingredients may include, without limitation, Maca, Tinospora Cordiofolia, Asparagus Racemosus, Orchis Latifolia, Tribulus Terrestris, Anacylus Pyrethrum, L-dopa, Epimedium, King Oyster mushrooms, Vitamin-B6, Ginseng, and D-aspartic acid. The herbal dietary supplement is aimed at enhancing sexual performance and energy levels. The herbal dietary supplement focuses on testosterone and libido rather than stress management.
[0005] In another patent literature, US20210379134A1 discloses a synergistic herbal composition comprising extracts of Mucuna pruriens, Cynara cardunculus, Trigonella foenum graecum, Withania somnifera and L-arginine along with pharmaceutically acceptable excipients, having libido enhancing, testosterone levels increasing and ejaculation delaying properties. This composition aims to enhance libido, increase testosterone levels, and delay ejaculation. Although the synergistic herbal composition includes Withania somnifera, the primary application of which is in sexual health, not stress reduction or performance enhancement.
[0006] Another patent literature IN201941005346 discloses a synergistic herbal composition comprising extracts of Mucuna pruriens, Cynara cardunculus, Trigonella foenum graecum, Withania somnifera and L-arginine along with pharmaceutically acceptable excipients, having libido enhancing, testosterone levels increasing and ejaculation delaying properties. However, the proposed composition is designed for sexual health rather than cognitive and stress-related benefits.
[0007] In another patent literature 4002/CHE/2014 discloses a synergistic fertility herbal formulation for men. The synergistic fertility herbal formulation comprises an effective group of compounds derived from natural sources preferably plants, fruits, seeds, tubers and flower buds of hordeum vulgare, mucuna pruriens, daucus carota, foeniculum vulgare, withania somnifera, crocus sativus, safed musli, trigonella foenum graecum linn, piper nigrum and ocimum sanctum. The synergistic fertility herbal formulatiom comprises various naturals extracts are used for treating low sperm count and low sperm motility and also act as male libido enhancer and energy supplement for men without any side effects. However, such formulation addresses male fertility issues, particularly low sperm count and motility, and enhances libido and energy. While the proposed composition utilizes some similar herbal extracts, the proposed composition does not focus on cognitive enhancement or stress reduction.
[0008] In a patent literature, 549/DEL/2011 discloses a female aphrodisiac herbal composition for natural treatments for the individuals suffering from lack of sexual desire and an arousal disorders. The female aphrodisiac herbal composition of the present invention increased blood circulation to the clitoris, increases stamina, increases sex drive with prolonged performance and further enhancing the female fertility. The aphrodisiac herbal composition comprises extracts or particulate material from the plants Withania Somnifera, Asparagus Racemosus, Mucuna Pruriens, Glycyrrhizia Glabra, Trigonella Foenum, Zingiber Officinale, Tribulus Terrestris, Asphalt and Curculigo Orchodes. The aphrodisiac herbal composition is a comprehensive herbal sex power, physical and mental health booster that helps revival of vigor, vitality and physical strength. However, such composition is intended for female sexual health rather than stress management and cognitive function.
[0009] In a patent literature, 2642/MUM/2009 discloses a composition for supporting sexual function and general wellbeing comprising combination of herbal extracts including extracts of Tribulus terrestris, Mucuna pruriens, Ginkgo biloba and Yohimbe bark with L-Arginine and Zinc to provide the synergistic activity on physiological parameters of libido, erection, orgasm and improvement in semen parameters. The compositions are formulated in the form of nutraceutical or pharmaceutical formulations. The emphasis here is on sexual health and reproductive parameters rather than cognitive and stress-related benefits.
[0010] In another patent literature, US9486482 describes a synergistic herbal composition comprising extracts of herbal ingredients of Tribulus terrestris, Withania somnifera, Curculigo orchioides, Mucuna pruriens, Asparagus adscendens, Asteracantha longifolia, Asphaltum, and optionally the extracts of Piper longum and Anacyclus pyrethrum for the treatment of disorders associated with Male Sexual Dysfunction. While beneficial for male sexual health, such composition does not address the broader cognitive and stress-related issues targeted by the current invention.
[0011] In another patent literature, IN201621011362 discloses nutraceutical supplement comprising the effective amount of Chlorophytum arundinacium, Withania somnifera, Mucuna pruriens, Pueraria tuberosa, Bombax ceiba, Phoenix dactylifera, Cicer arientinum, Hordeum vulgare and Saccharum officinarum for use in prophylaxis or treatment of aphrodisiac activity. Although the nutraceutical supplement includes Withania somnifera, its primary focus is on aphrodisiac activity rather than stress reduction or cognitive enhancement.
[0012] In another patent literature, 3119/DEL/2013 discloses an herbal aphrodisiac composition for men which also act as tonic to treat other sexual dysfunction which comprises of Trigonellafoenum-graecum 100 mg to 1000 mg, Tribulus terrestris 50 mg to 500 mg, Chlorophytum bormlUanum 50 mg to 500 mg, Asphaltum punjabianum 50 mg to 250 mg. Wherein, such formulation is aimed at sexual health improvements, differing from goal of enhancing cognitive function and managing stress.
[0013] While these prior arts contribute significantly to their respective fields, but the existing technologies are devoid of ensuring a synergistic effect of both performance enhancement and stress management, that promote overall mental well-being.
[0014] Therefore, in order to avoid such problems, there is a need for a novel and advanced nutraceutical formulation that addresses common cognitive and stress-related issues through a unique blend of herbal extract. The present disclosure is directed to overcome one or more limitations stated above, and any other limitation associated with the prior arts.
SUMMARY
[0015] 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.
[0016] The present invention is directed to a nutraceutical dietary supplement formulation. The formulation comprising a blend of Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, Cynara cardunculus extract; saffron (Crocus sativus) extract; gokshura (Tribulus terrestris); and pharmaceutically acceptable excipients. The pharmaceutically acceptable excipients include a diluent, a stabilizer, an anti-caking agent, a preservative, and a capsule shell.
[0017] 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
[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 natural dietary supplement formulation that reduces stress, enhances testosterone production, and boosts stamina, thereby improving overall physical and mental performance. Additionally, another objective of the present invention is to use a scientifically validated blend of natural ingredients in the formulation, ensuring that each component is backed by clinical research for its efficacy and safety in addressing stress, low testosterone levels, and poor stamina.
[0022] Also, the present invention offers a solution that is free from steroids and heavy metals, ensuring long-term safety without the risk of adverse side effects or dependency, making it suitable for a broad range of individuals seeking performance enhancement. Further, the present invention ensures that the formulation is non-habit forming and can be used safely over the long term, without steroids and heavy metals, to prevent dependency or harmful side effects.
[0023] The present invention provides a user-friendly dietary supplement that can be conveniently administered, making it easy for users to incorporate into their daily routines, designed for oral consumption. Furthermore, the present invention aims to achieve a balance between enhancing physical performance and reducing stress, addressing both physical stamina and mental well-being, to improve overall quality of life.
[0024] 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.
[0025] The present invention provides a nutraceutical dietary supplement formulation. The formulation comprising a blend of Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, Cynara cardunculus extract; saffron (Crocus sativus) extract; gokshura (Tribulus terrestris); and pharmaceutically acceptable excipients. The pharmaceutically acceptable excipients include a diluent, a stabilizer, an anti-caking agent, a preservative, and a capsule shell. Such composition provides a novel dietary supplement formulation designed to combat stress, enhance testosterone production, and boost stamina, ultimately improving overall performance. The unique formulation addresses the root causes of poor performance by providing a triple-action blend of natural ingredients, each selected for their specific health benefits and clinical efficacy.
[0026] The proposed blend is a potent combination of four key ingredients: Trigonella foenum-graecum extract, Withania somnifera extract, Mucuna pruriens extract, L-Arginine, and Cynara cardunculus extract. Such ingredients have been meticulously chosen for their proven ability to enhance testosterone levels and improve stamina. Trigonella foenum-graecum (Fenugreek) extract is known for its ability to support healthy testosterone levels, thereby improving muscle strength and vitality. Withania somnifera extract, a renowned adaptogen, helps the body manage stress while also supporting overall energy levels. Mucuna pruriens extract aids in boosting libido and testosterone levels, contributing to better performance. L-Arginine, an amino acid, is crucial for nitric oxide production, which improves blood flow and endurance. Further, the Cynara cardunculus (i.e., artichoke) extract contains the bioactive agents such as cynarin, luteolin, and catechins. The artichoke extract is shown to inhibit an enzyme called phosphodiesterase-5 (PDE5). PDE5 is an enzyme that is involved in termination of NO-mediated Current Good Manufacturing Practice (cGMP) actions on endothelial cells of blood vessels. Action of cGMP is important for proper penile erection and inhibition of its action leads to erectile dysfunction (ED). PDE5 enzyme is considered as one of the drug targets for the treatment of ED.20. The active luteolin compounds are found to be pro-erectile through PDE5 inhibition.
[0027] Another significant component of the formulation is Saffron extract, derived from the stigma of the Crocus sativus flower. Saffron is well-known for its stress-relieving properties and has been used traditionally to alleviate anxiety and enhance mood. The extract's potent antioxidant properties help to neutralize free radicals, reducing oxidative stress on the body. Clinical studies have shown that saffron can significantly reduce stress and anxiety levels, contributing to a more balanced mental state and improved overall well-being;
[0028] The third key ingredient i.e., Gokshura (Tribulus terrestris), is an herb traditionally used to enhance physical performance and boost testosterone levels. Gokshura is recognized for its ability to increase stamina and endurance naturally. Gokshura supports the body's natural testosterone production, which is essential for muscle growth, strength, and overall vitality. The herb also aids in reducing fatigue, enabling individuals to perform at their best.
[0029] In addition to these primary ingredients, the formulation includes several inactive ingredients that enhance the product's stability and bioavailability. These inactive ingredients are the pharmaceutical excipients, 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, stabilizer, anti-caking agent, preservative, capsule shell different functional groups enhancing the taste, stability and effectiveness of the formulation as excipients.
[0030] In one embodiment, 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, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, and Sodium starch glycolate. 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), PPO (Polypropylene oxide), and crospovidone’ in stabilizer group. The anti-caking agent selected from a group consisting of one of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, and Yellow prussiate of soda.
[0031] Further, the preservative is selected from a group consisting of one Benzalkonium chloride, Benzoic acid, Benzyl alcohol, Methylparaben, Parabens, Phenoxyethanol, Erythorbic acid, Phenol, Quaternary ammonium cation, Alcohols, Potassium Sorbate, Potassium benzoate, Chlorobutanol, Phenylethyl alcohol, Propylparaben, and Sodium. The capsule shell is selected from a group consisting of one Hydroxypropyl methylcellulose, Polyvinyl alcohol (PVA), and starch.
[0032] The formulation is prepared to be free from steroids, non-habit forming, and devoid of heavy metals, ensuring that it is safe for long-term use without the risk of adverse side effects. Such technique makes the product suitable for a wide range of individuals seeking a natural and effective solution to improve their performance.
[0033] The formulation functions by harnessing the combined effects of its natural components, including a proprietary blend of extracts and nutrients, to target specific bodily mechanisms related to stress, testosterone production, and stamina. The proposed blend supports healthy testosterone levels, aids in stress management and energy enhancement, contributes to libido and testosterone levels, and supports nitric oxide production for improved blood flow and endurance.
[0034] 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.
[0035] The present invention provides a nutraceutical formulation comprising Saffron extract, Licorice extract, Bael extract, Inulin, Sodium bicarbonate, Probiotic blend, Peppermint oil extract.
[0036] This innovative formulation combines various herbal extracts, vitamins, and active compounds. It offers a non-habit-forming solution to enhance performance, and boost energy while managing cortisol levels and reducing stress. The formulation includes a blend of Mucuna pruriens Extract, Trigonella feanum-greacum extract, Withania somnifera extract, L-arginine, Cynara cardunculus extract and essential ingredients like Crocus sativus L., Tribulus terrestris Linn., all formulated with pharmaceutically accepted excipients to provide these benefits without artificial colors or added sugars.
[0037] 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
Proprietary Blend of Extracts and Nutrients 1. Mucuna pruriens,
2. Trigonella foenum-graecum,
3. Withania somnifera,
4. L-Arginine,
5. Cynara cardunculus Seed
Seed

Root

Leaves France

Mediterranean basin for Cyanra cardanuculus
Saffron Extract Crocus sativus Stigma Iran
Gokshura Tribulus terrestris Fruit India
Table 1
[0038] In one embodiment, the present invention discloses the nutraceutical dietary supplement formulation comprising herbal extracts of:
1. the blend of extracts and nutrients, which includes Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, and Cynara cardunculus extract, is present in an amount of 45% to 65% by weight
2. the saffron extract is present in an amount of 1% to 5% by weight
3. the Gokshura is present in an amount of 15% to 25% by weight of the total weight of the composition and pharmaceutically acceptable excipients.
[0039] Further, the pharmaceutical acceptable excipients used in the present invention are:
1. the diluent in an amount ranging from 10% to 20% by weight;
2. the stabilizer in an amount ranging from 1% to 5% by weight;
3. the anti-caking agent in an amount ranging from 1% to 3% by weight
4. the preservative in an amount ranging from 0.001% to 3% by weight
5. the capsule shell in an amount ranging from 10% to 20% by weight of the total weight of the composition.
[0040] In an exemplary embodiment, the blend of extracts and nutrients, which includes Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, and Cynara cardunculus extract is present in an amount of 57.97% by weight, saffron extract is present in an amount of 2.17% by weight, Gokshura is present in an amount of 21.73% by weight of the total weight of the composition and pharmaceutically acceptable excipients.
[0041] Wherein, in the aforementioned exemplary embodiment, the pharmaceutical acceptable excipients used in the present invention are:
1. the diluent in an amount of 13.93% by weight;
2. the stabilizer in an amount of 3% by weight;
3. the anti-caking agent in an amount of 1% by weight;
4. the preservative in an amount of 0.02% by weight;
5. the capsule shell in an amount of 16.25% by weight;
[0042] In another exemplary embodiment, the present invention discloses a synergistic composition comprising herbal extracts of:
1. the blend of extracts and nutrients, which includes Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, and Cynara cardunculus extract, is present in a range of 400 mg to 500 mg per capsule;
2. Saffron extract is included in a range of 10 mg to 20 mg per capsule; and
3. Gokshura is included in a range of 100 mg to 200 mg per capsule of the total weight of the composition and pharmaceutically acceptable excipients.
[0043] The formulation is designed to be introduced into an individual orally, in the form of tablets, capsules, powders, or liquids. The proprietary blend of extracts and nutrients is introduced into the gut of the individual, where the active components are absorbed and begin to exert their effects. The extracts and nutrients in the formulation work synergistically to support various physiological processes that contribute to reduced stress and enhanced performance.
[0044] The proposed formulation leverages the combined benefits of its ingredients to create a comprehensive approach to stress reduction and performance enhancement. By addressing both physical and mental aspects of well-being, the formulation helps individuals achieve a balanced and enhanced state of health.
[0045] The ingredients work together to improve mood, reduce stress, enhance stamina, and boost testosterone levels, leading to improved overall performance. The proprietary blend of extracts and nutrients, along with saffron extract and Gokshura, provides a comprehensive solution for individuals seeking to manage stress and improve performance. By incorporating this formulation into their daily routine, individuals can experience significant improvements in their mental and physical well-being, leading to a more balanced and productive life.
[0046] In one embodiment, the method involved in the preparation of the perform capsule formulation is illustrated below. The method comprises weighing and sifting of all the Raw Materials, mixing of all active ingredients and preservatives, filling of the capsules as per specified filling weight. The method further includes performing quality testing and polishing of capsules, and filling of capsules in bottles.
Experimental and Clinical Trial Details:
[0047] A study was conducted on healthy male individual, aged between 18 to 40 years, 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 1318 mg 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 CBC, LFT, and RFT parameters, as well as Sexual Desire Inventory (SDI) score and Perceived Stress levels using standardized scales. Adverse events were also monitored throughout the study period.
[0048] 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, and conducted in accordance with the approved protocol and ICH-Good Clinical Practices (GCP) guidelines.
[0049] 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.
[0050] 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.
[0051] 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 Sexual Desire Inventory (SDI) score, changes in self-reported Likert scale 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.
[0052] 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.
[0053] Inclusion Criteria:
1. Healthy male individuals aged between 18 to 40 years (both inclusive) were included in the study.
2. A subject experiencing a perceived impact on sexual desire, vitality, stamina, and performance was included.
3. A subject suffering from mild stress on the Perceived Stress Scale (PSS).
4. Subjects should be in an active stable sexual relationship for the entire duration of the study.
5. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
6. Subjects were willing to follow up.
[0054] Exclusion Criteria:
1. Subjects who had undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs were excluded from the study.
2. Subjects who were already taking any drug or therapy that may have a relation with erectile dysfunction (such as nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.) were excluded.
3. Participants with a history of substance abuse, drug use, heavy alcohol consumption, and/or smoking were excluded from the study.
4. Participants with neurological conditions and those who had undergone recent surgeries were excluded from the study.
5. Participants with comorbidities who were consuming ayurvedic or dietary supplements for the said indication for the past three months were not included in the study.
6. Subjects with any other clinical condition deemed unsuitable for study participation by the investigator were excluded.
Result of the Study:
[0055] Demographic characteristics – All thirty male participants successfully completed the study. The average age of the subjects was 33.53±4.63 years. The participants had an average weight of 66.93 kg, an average height of 165.13 cm, and an average BMI of 24.49 kg/m². These values fall within clinically acceptable ranges. The demographic details are summarized in the table below. These demographic details are summarized in Table 2.
Parameter Mean ± S.D.
Average Age (Years) 33.53 ± 4.63
Height (cm) 165.13 ± 6.21
Weight (kg) 66.93 ± 11.35
BMI (kg/m2) 24.49 ± 3.12
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.
[0056] Assessment of hematological and biochemical investigations – There was a statistically significant decrease in the white blood cell count (WBC) from screening to day 30 (p = 0.016). Additionally, the mean corpuscular hemoglobin concentration (MCHC) increased significantly over the same period (p = 0.0004).
[0057] In the kidney function tests, the mean urea levels showed a significant increase from screening to day 30 (p = 0.001), while the mean creatinine levels decreased significantly (p = 0.001). The mean uric acid levels also decreased significantly from screening to day 30 (p = 0.007). No statistically significant changes were observed in the remaining hematological parameters, including RBC, hemoglobin, hematocrit, MCV, MCH, and platelet count, as well as the liver function tests, between screening and day 30. However, these changes were not clinically significant, indicating that the investigational product was well-tolerated by the study participants. The investigation details are illustrated in Table 3.
Parameter Reference Range Day 0
(Mean ± SD) Day 30 (Mean ± SD) P Value Significant (p < 0.05)
White Blood Cell Count (WBC) 4000 - 11000 cell/cu.mm 8166.67 ± 2065.03 7223.33 ± 1703.48 0.016* Yes
Red Blood Cell Count (RBC) 4.7 - 6.0 mil/cu.mm 4.92 ± 0.67 4.69 ± 0.62 0.202 No
Hemoglobin (Hb) Female: 11.6 - 15 gm/dL 13.07 ± 2.09 13.60 ± 1.74 0.244 No
Male: 13.2 - 16.6 gm/dL
Hematocrit (PCV) 42 - 52 % 40.98 ± 5.67 40.80 ± 6.12 0.906 No
Mean Corpuscular Volume (MCV) 78 - 100 fL 84.47 ± 9.02 82.94 ± 11.95 0.351 No
Mean Corpuscular Hemoglobin (MCH) 27 - 31 pg 27.49 ± 3.71 26.70 ± 4.57 0.443 No
Mean Corpuscular Hemoglobin Concentration (MCHC) 32-36 gm/dL 32.06 ± 1.12 33.11 ± 1.02 0.0004* Yes
Platelet Count 150 - 450 10^3/ul 297.27 ± 50.04 301.50 ± 83.64 0.764 No
Neutrophils 40 - 75 % 58.20 ± 6.17 56.03 ± 6.63 0.137 No
Lymphocytes 20 - 40 % 36.00 ± 4.84 35.30 ± 6.19 0.513 No
Monocytes 2 - 10 % 4.87 ± 1.11 4.57 ± 1.61 0.378 No
Eosinophils 1 - 6 % 4.00 ± 0.37 3.70 ± 0.75 1.000 No
Basophils 0 - 1 % 0.00 ± 0.00 0.00 ± 0.00 1.000 No
Protein Total 6.0 - 8.3 g/dL 7.04 ± 0.52 7.09 ± 0.67 0.634 No
Albumin 3.2 - 5.5 g/dL 4.46 ± 0.45 4.49 ± 0.51 0.565 No
Globulin 1.8 - 3.6 g/dL 2.58 ± 0.36 2.59 ± 0.38 0.845 No
A/G Ratio 1.2 - 2.2 1.76 ± 0.31 1.76 ± 0.31 0.949 No
Bilirubin Total 0.1 - 1.2 mg/dL 0.62 ± 0.36 0.62 ± 0.32 0.322 No
Bilirubin Direct 0 - 0.4 mg/dL 0.23 ± 0.12 0.24 ± 0.11 0.327 No
Bilirubin Indirect 0.1 - 0.8 mg/dL 0.39 ± 0.28 0.37 ± 0.27 0.449 No
Aspartate Transaminase (AST/SGOT) 49 U/L 29.85 ± 11.79 29.55 ± 7.64 0.823 No
Alanine Transaminase (ALT/SGPT) 49 U/L 26.61 ± 9.51 27.30 ± 8.83 0.347 No
Alkaline Phosphatase 80 - 306 U/L 140.06 ± 48.28 139.96 ± 49.36 0.961 No
Urea 7 - 40 mg/dL 20.54 ± 5.44 27.30 ± 8.83 0.001* Yes
Creatinine 0.5 - 1.5 mg/dL 0.87 ± 0.24 0.71 ± 0.33 0.001* Yes
Uric Acid 3.0 - 7.2 mg/dL 4.17 ± 0.89 3.96 ± 0.86 0.007* Yes
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.
[0058] Assessment of vital signs – Respiratory rate showed a statistically significant decrease from screening to day 30 (17.30±1.09, p = 0.012). However, other vital parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and body temperature, did not show statistically significant changes from screening to day 30 as demonstrated in the table below.
[0059] All thirty subjects were compliant and showed excellent tolerability to the investigational product, as indicated in Table 4.
Parameter Day 0
(Mean ± SD) Day 30 (Mean ± SD) P Value Significant (p < 0.05)
Systolic Blood Pressure (mmHg) 124.00 ± 6.67 121.63 ± 10.73 0.220 No
Diastolic Blood Pressure (mmHg) 78.17 ± 6.38 77.13 ± 6.57 0.516 No
Heart Rate (beats per minute) 77.20 ± 6.22 77.90 ± 9.70 0.644 No
Body Temperature (°F) 97.30 ± 0.92 97.24 ± 0.77 0.735 No
Respiratory Rate (breaths per minute) 18.27 ± 1.57 17.30 ± 1.09 0.012* Yes
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.
[0060] Assessment of adverse events – Out of the 30 participants, a total of 4 subjects (13.33%) experienced at least one adverse event as illustrated in Table 5. The most commonly reported adverse events were heartburn, fever, vomiting, and headache. For each adverse event, the number of subjects affected and the corresponding rescue medication used are shown. The adverse events observed were not related to the investigational product.
Adverse Event No. of Subjects (N=30) Rescue Medication
Heartburn 1 Omeprazole
Fever 1 Paracetamol
Vomiting 1 Pantoprazole
Headache 1 Aspirin
Total No. of Events 4 -
Total No. of Subjects (%) 4 (13.33%) -
Table 5
[0061] Assessment of perceived stress using perceived stress scale – The Perceived Stress Scale (PSS) comprises ten-question questionnaire with responses ranging from 0 to 4, measuring an individual's perception of stress. The total score is the sum of all responses, indicating the perceived stress level. Scores range as follows: 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress).
[0062] The assessment of perceived stress using the PSS demonstrated a statistically significant decrease of 61.35% after 30 days of treatment as illustrated in Table 6. The observed change in the PSS score was statistically highly significant, suggesting a clinically meaningful improvement in the participants' subjective experience of stress.
Duration PSS Score (n=30) P value
Day 0 22.07±2.46 <0.001
Day 30 8.53±3.36
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.
[0063] Assessment of Changes in Self-Reported Stamina on a 4-Point Likert Scale – The assessment of changes in self-reported stamina was conducted using a 4-point Likert scale, where 0 represented low stamina, 1 represented good stamina, 2 represented better stamina, and 3 represented highly improved stamina.
[0064] At screening, 10 participants reported low stamina, and 20 reported good stamina as illustrated in Table 7. After 30 days of treatment, all participants (100%) shifted to the better-highly improved stamina category.
Parameter Score Day 0 (n=30) Day 30 (n=30)
Stamina 0 10 0
1 20 0
2 0 21
3 0 9
Table 7
[0065] Assessment of Sexual Desire Using the Sexual Desire Inventory (SDI) Score – The Sexual Desire Inventory (SDI) is a 13-item questionnaire that evaluates an individual's level of sexual desire. Responses are scored from 0 (no desire) to 8 (strong desire), with the total score calculated by summing all responses. A higher total score indicates a greater level of sexual desire.
[0066] The SDI assessment showed a notable 62.34% increase in self-reported sexual desire scores after 30 days of treatment, indicating a statistically significant improvement as illustrated in Table 8.
Duration SDI Score (n = 30) P Value
Day 0 38.13±6.77 <0.001
Day 30 61.90±6.87
Table 8
[0067] 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.
[0068] 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.
[0069] 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 dietary supplement formulation, the formulation comprising:
a blend of Mucuna pruriens extract, Trigonella foenum-graecum extract, Withania somnifera extract, L-Arginine, and Cynara cardunculus extract;
saffron (Crocus sativus) extract;
gokshura (Tribulus terrestris); 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, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, and Sodium starch glycolate;
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) crospovidone’ in stabilizer group;
an anti-caking agent selected from a group consisting of one of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, and Yellow prussiate of soda;
a preservative selected from a group consisting of one Benzalkonium chloride, Benzoic acid, Benzyl alcohol, Methylparaben, Parabens, Phenoxyethanol, Erythorbic acid, Phenol, Quaternary ammonium cation, Alcohols, Potassium Sorbate, Potassium benzoate, Chlorobutanol, Phenylethyl alcohol, Propylparaben, and Sodium; and
a capsule shell selected from a group consisting of one Hydroxypropyl methylcellulose, Polyvinyl alcohol (PVA), and starch.
3. The formulation as claimed in claim 1, wherein the formulation comprises:
the blend in an amount of 45% to 65% by weight;
the saffron extract in an amount of 1% to 5% by weight;
the gokshura in an amount of 15% to 25% 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 diluent in an amount ranging from 10% to 20% by weight;
the stabilizer in an amount ranging from 1% to 5% by weight; and
the anti-caking agent in an amount ranging from 1% to 3% by weight;
the preservative in an amount ranging from 0.001% to 3% by weight; and
the capsule shell in an amount ranging from 10% to 20% by weight.