| CTRI Number |
CTRI/2024/11/076576 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of Shilajit gummies on improving the health of middle-aged men. |
|
Scientific Title of Study
|
A double-blind, placebo-controlled study on the impact of Shilajit gummies on sexual wellness, energy, and metabolic health in revitalizing middle-aged male health. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/039 Version 1.00 Dated 18/10/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Health Nexus Research Centre |
| Address |
Sai Chowk, Sarathi Housing Society, Shahunagar,
Pimpri Chinchwad
Pune MAHARASHTRA 411019 India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Darshani Mohan |
| Designation |
Associate Director R&D Food and Nutra |
| Affiliation |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Road, Kapurbawdi, Thane West
Mumbai MAHARASHTRA 400610 India |
| Phone |
9677449243 |
| Fax |
- |
| Email |
darshani.m@mosaicwellness.in |
|
Details of Contact Person Public Query
|
| Name |
Shreyans Jain |
| Designation |
Senior Manager NPD |
| Affiliation |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Road, Kapurbawdi, Thane West
Mumbai MAHARASHTRA 400610 India |
| Phone |
07506946496 |
| Fax |
- |
| Email |
shreyans.jain@mosaicwellness.in |
|
|
Source of Monetary or Material Support
|
| Mosaic Wellness Pvt Ltd 6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Rd, Kapurbawdi, Thane West, Thane, Maharashtra 400610 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Rd, Kapurbawdi, Thane West, Thane, Maharashtra 400610 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D G Dipankar |
Dr. D. Y. Patil College of Ayurved & Research Centre |
Sant Tukaram Nagar, Pimpri, Pune – 411018
Maharashtra, India. Pune MAHARASHTRA |
9822279321 - digambar.dipankar@dpu.edu.in |
| Dr Ramshyam Agarwal |
Health Nexus Research Centre |
Sai Chowk, Sarathi Housing Society, Shahunagar,
Pimpri Chinchwad
Pune MAHARASHTRA |
8087282022 - ramshyam.research@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Dr. DYPCA & RC Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Two Shilajit gummies in sequence once daily after a major meal for 90 days. |
| Comparator Agent |
Group B |
Two Placebo gummies in sequence once daily after a major meal for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1. Male participants aged 45-55 years (both inclusive) with BMI not more than 30 kg per meter square 2. Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit 3. Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III) -serum triglycerides: greater than or equal to 150 mg per dL, HDL cholesterol- less than or equal to 40 mg per dL in men, blood pressure- greater than or equal to 130 mm Hg systolic or greater than or equal to 85 mm Hg diastolic, fasting plasma glucose greater than or equal to 100 mg per dL, Abdominal obesity, waist circumference: men greater than 90 cm 4. Participants should be in an active stable sexual relationship for the entire duration of the study 5. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Previous events or other severe conditions that may affect sexual health or metabolic health
2. Participants with genital anatomical deformities, including but not limited to penile deformities
3. Participants for whom sexual activity is inadvisable because of their underlying disease status
4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
5. Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical trial outcomes
6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs
7. Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year
8. Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day
9. Any concomitant treatment that is not permissible including but not limited to nitrates, anti androgens, chemotherapy agents, radiotherapy, etc.
10. Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
11. Known hypersensitivity to any of the ingredients of the investigational product
12. Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceuticals, or ayurvedic supplement for sexual health & well-being
13. Participants consuming any nutraceutical, herbal, or ayurvedic supplement for any other condition
14. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Changes in free testosterone and total testosterone levels
2.Changes in libido system score (LSS) score.
3.Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) score.
4.Metabolic Syndrome Severity Z Score (MetZ score).
MetZ score is derived from five key components of Metabolic Syndrome (waist circumference, triglycerides, HDL cholesterol, systolic blood pressure, and fasting plasma glucose)
5.Changes in cardiorespiratory endurance by VO2 max by step test. |
screening, day 30, day 60 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in anthropometric parameters including body weight (kg), waist circumference and BMI.
2. Changes in Fatigue Severity Scale (FSS) score.
3. Changes in energy levels assessed by energy audit diary.
4. Changes in Profile of Mood State (POMS) questionnaire score.
5. Changes in perceived stress scale-10 (PSS-10) score. |
1. at screening, day 30, day 60 and day 90
2. at screening, day 30, day 60 and day 90
3. at screening, day 30, day 60 and day 90
4. at screening and day 90
5. at screening, day 30, day 60 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sexual dysfunction and associated metabolic syndrome are common health problems among middle-aged men and can significantly impact their quality of life. Sexual dysfunction can result from low testosterone and low or elevated thyroid hormones. Their management necessitates a tailored approach considering the underlying etiology, severity, and associated medical conditions. Decreased libido is a common concern, often influenced by factors like age, mental health, and hormonal changes. While it’s a natural part of aging, conditions like late-onset hypogonadism (LOH) can contribute to more significant declines. Nutraceutical supplements may offer potential support for maintaining healthy libido and overall well-being. While conventional therapies exist, they often exhibit adverse health effects. Conversely, phytotherapeutic interventions offer a more efficacious approach to managing diseases by modulating biological processes such as inflammation, oxidative stress, and intracellular signaling. Numerous medicinal plants have been documented to exert beneficial effects on erectile function. The hypothalamus’s role in converting testosterone to estradiol may be crucial for testosterone’s effects on libido. Some herbs have also been shown to increase testosterone levels in men. A recent study highlighted a strong connection between libido and cardiovascular diseases, suggesting that preserving libido may positively impact cardiovascular health and overall well-being in men. The rationale for this study centers on the vital role of supplement in maintaining sexual wellness, metabolic health, energy level and overall well-being in middle aged men. Sexual dysfunction, impotence, and related issues have been a longstanding challenge for the scientific community and medical practitioners. These conditions can have significant psychosocial implications, affecting men in various ways. There has been a continuous search for novel herbal and chemical agents to address the persistent battle to combat sexual dysfunction and maintain metabolic and sexual health with increasing age. This randomized, double-blind, placebo-controlled clinical trial will evaluate the impact of Shilajit gummies on sexual wellness, energy, and metabolic health in revitalizing middle-aged male health. By integrating traditional therapeutic principles with modern scientific research, this study aims to offer a comprehensive and holistic approach to restoring energy, sexual wellness, metabolic health, and testosterone levels and enhancing overall well-being. |