| CTRI Number |
CTRI/2024/11/076364 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of Shilajit gummies in improving health life in males. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study of Shilajit gummies to evaluate the efficacy focusing on their impact on energy levels, fatigue reduction, and muscle mass increase in males. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/041 Version: 1.00; Dated 19th Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketan Kshirsagar |
| Designation |
Senior Consultant |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd |
| Address |
OPD Room no 01,1st floor,Krushna
Chowk, Krushna Nagar, New Sangvi
Pune
MAHARASHTRA
411027
India |
| Phone |
9049002749 |
| Fax |
- |
| Email |
drketan.sangvihospital@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 Bussiness IT park Thane One, Ghodbunder Rd, 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 Bussiness IT park Thane One, Ghodbunder Rd, Kapurbawdi, Thane West
Mumbai
MAHARASHTRA
400610
India |
| Phone |
7506946496 |
| Fax |
- |
| Email |
shreyans.jain@mosaicwellness.in |
|
|
Source of Monetary or Material Support
|
| Mosaic Wellness Pvt Ltd
6XCG 9F3, Thane One Corporate Bussiness 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 Bussiness 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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketan Kshirsagar |
Sangvi Multispeciality Hospital Pvt. Ltd |
OPD Room no 01,1st floor,Krushna
Chowk, Krushna Nagar, New Sangvi.
Pune
MAHARASHTRA |
9049002749
-
drketan.sangvihospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Placebo gummies |
Two Placebo gummies in sequence once daily after a major meal for 60 days. |
| Intervention |
Shilajit gummies |
Two Shilajit gummies in sequence once daily after a major meal for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1.Male participants aged between 18-40 years having BMI less than 35 kg per m2;2.Resting blood pressure averaging less than 140 by 90 mmHg;3.Not on any medication for cardiovascular and metabolic disorders;4.Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study;5.Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator;6.Willing to provide consent and come for regular follow-up visits. |
|
| ExclusionCriteria |
| Details |
1.Participants with any acute illness requiring immediate medical care;
2.Participants with any chronic medical condition;
3.Participants with sedentary lifestyle not able or not advised to undergo the resistance training as per protocol;
4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion;
5.Any other condition which proves participant unfit for the study participation;
6.Any known cardiovascular or metabolic disease;
7.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation;
8.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in muscle strength using a standard plate loaded leg press and chest press machine, Rep max for leg press and chest press at screening and day 60.
2.Changes in muscle endurance using a standard plate loaded leg press and chest press machine by measuring Reps to fatigue at 50 percent 1 Rep Max at screening and day 60.
3.Changes in hypertrophy measurements of at three sites that is arm (flexed mid upper arm), chest (sternum at mid tidal volume) and upper thigh (just inferior to gluteal fold) (in cm) at screening and day 60.
4.Changes in the rating of perceived exertion at screening, day 30 and day 60. Modified to encompass the entire training day. 1 to 10 scale as to how hard that workout was. The higher the scale score, the harder the workout felt to the participant.
5. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS),48 hours at screening, day 30 and day 60. |
Screening, day 30 and day 60 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Changes in serum total testosterone, free testosterone levels & cortisol levels at screening & day 60.
2.Changes in muscle damage markers creatine kinase (CK), at Pre Exercise Bout, Immediate Post Exercise Bout & 24 Hours Post-Exercise Bout at screening & day 60.
3.Changes in cardiorespiratory endurance by VO2 max by harvard step test at screening, day 30, & day 60.
4.Changes in percent fat & skeletal muscle mass using BIA at screening & day 60.
5.Changes in anthropometric parameters body weight (kg), BMI (Kg per m2) at screening, Day 30 & day 60. |
Screening, day 30 & day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
07/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The rationale for this formulation lies in the synergistic interaction of Shilajit, Ashwagandha, Ginger, Black Pepper, Mucuna Pruriens, and Akarkara, all of which have scientifically proven benefits in enhancing muscle strength, endurance, testosterone levels, and post-exercise recovery. The proposed clinical trial will use a randomized, double-blind, placebo-controlled design to rigorously evaluate the efficacy of this formulation in healthy adults engaged in regular physical activity. Shilajit, the core ingredient, is rich in fulvic acid and essential minerals, enhancing mitochondrial function and ATP production. Studies have demonstrated its ability to increase endogenous testosterone levels and support muscle recovery by reducing oxidative stress and inflammation. These effects are crucial for improving overall physical performance, especially in exercise-induced fatigue. Ashwagandha, a potent adaptogen, has been extensively studied for its ability to increase VO2 max, reduce cortisol, and promote muscle strength and endurance. Research shows that it supports post-exercise recovery by modulating the hypothalamic-pituitary-adrenal axis, reducing stress, and improving muscle repair. Ginger’s anti-inflammatory and antioxidant properties help reduce muscle soreness, while Mucuna Pruriens, through its L-DOPA content, stimulates dopamine production, supporting testosterone synthesis and muscle hypertrophy. Black Pepper enhances the bioavailability of these active compounds, ensuring maximum absorption and efficacy. Akarkara, a lesser-known traditional herb, has shown promise in enhancing physical strength and vitality. This scientifically driven formulation aims to optimize muscle recovery, enhance physical performance, and boost testosterone levels. By conducting a well-designed randomized controlled trial, this study will provide robust evidence to support the use of this combination in improving muscle strength, endurance, and recovery in physically active individuals. The study has completed and the data is available with the sponsor of the study on individual request basis.
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