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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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