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CTRI Number  CTRI/2024/05/066815 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Clinical Study to Evaluate the Efficacy and Safety in Healthy Adults for a period of 2 months for the safety endpoints. 
Scientific Title of Study   A Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Meet Shilajeet Supplement on Improving Vitality, Boosting stamina, Strength and Performance in Healthy Adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
TG/CLI/083, Version 2.0, 08 Apr 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachana K L 
Designation  Principal Investigator 
Affiliation  TrialGuna Private Limited 
Address  467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560083
India 
Phone  08867125414  
Fax    
Email  dr.klr.lucky@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachana K L 
Designation  Principal Investigator 
Affiliation  TrialGuna Private Limited 
Address  467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560083
India 
Phone  08867125414  
Fax    
Email  dr.klr.lucky@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CRO representative  
Affiliation  TrialGuna Private Limited 
Address  467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560083
India 
Phone  09972636265  
Fax    
Email  meena@trialguna.com  
 
Source of Monetary or Material Support  
Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.) Village- Nayagaon, Chandansingh, Block-Kotabagh, PO Kamola, Nainital Uttarakhand-263139, India 
 
Primary Sponsor  
Name  Herbal Creations 
Address  Village-Nayagaon, Chandansingh, Block - Kotabagh, PO Kamola, Nainital, Uttarakhand-263139 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Meena Dalal  TrialGuna Private Limited  467, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA 		 08867125414

meena@trialguna.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male adults 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Meet Shilajeet  Route of Administration: Oral dosage Quantity: Meet Shilajeet supplement 500 mg capsule Twice a day treatment for 2 months 
Comparator Agent  Placebo  Route of Administration: Oral dosage quantity: Placebo Microcrystalline cellulose supplement 250 mg capsule Twice a day treatment for 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1) Healthy male adult subjects age between 18–45 years.
2) Participants with a body mass index (BMI) of 18.5–29.9 kg/m2
3) Willing to participate in an exercise program 2-3 times per week for 8 weeks.
4) Subjects should be available for duration of study period (8 weeks).
5) Express a willingness to actively participate in the study and provide informed consent. 
 
ExclusionCriteria 
Details  1) Individuals currently undertaking resistance training exercise.
2) Clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, renal, immunological, endocrine (such as uncontrolled diabetes or
thyroid disease), or haematological abnormalities.
3) Taking medication with corticosteroids, antidepressants, anticholinergics, or any other drugs that may have influenced the study outcome.
4) Severe pulmonary dysfunction (uncontrolled bronchial asthma and/or chronic obstruction).
5) History of orthopaedic conditions or surgeries that would interfere with exercise performance.
6) Completed any other clinical trial within 6 months prior to enrolment.
7) Consumed any dietary supplements or herbal drugs within 7 days prior to screening.
8) Known hypersensitivity to herbal drugs, nutritional supplements, or foods.
9) Active smokers or having a history of high alcohol intake (2 standard drinks per day) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Queens College Step Test to determine an individual aerobic endurance.
2) 6 Minute Walk Test to assess aerobic capacity and endurance.
3) 30 Second Sit to Stand Test to assess functional lower extremity muscle strength and
endurance.
4) Push up test to assess upper body strength and endurance.
5) Squat Test to assess lower body strength and endurance.
6) Change in testosterone and cortisol levels from baseline to the end of the study. 		 Day 0 & Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
1) Improvement in Quality of Life (SF-36) questionnaire scores from baseline to the end of the study.
2) The change in vital signs (blood pressure, pulse rate, body temperature) from baseline to the end of the study.
3) The changes in haematological (CBC), liver function and kidney function parameters from baseline to the end of the study.
4) Occurrence of the treatment-related adverse events during study period. 		 Day 0 & Day 60 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 05/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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)  

This study aimed to rigorously investigate the efficacy and safety of Meet Shilajeet through a randomized, placebo-controlled clinical trial. The primary focus will be on evaluating its impact on key parameters, including energy levels, strength, stress levels, and endurance, in a cohort of healthy adults. This research is designed to provide valuable insights into the potential benefits of Shilajeet supplementation and contribute to the growing body of scientific knowledge surrounding natural interventions for health optimization. The outcomes of this research may not only have implications for individual well-being but may also inform future discussions on the integration of traditional remedies into contemporary health practices. The study demonstrated significant improvements in the Meet Shilajeet treatment group across various physical performance and health-related quality of life measures compared to the placebo group. Participants receiving Meet Shilajeet Capsules showed enhanced lower and upper body strength, as evidenced by significant improvements of 28.55% in the Sit-to-Stand test, 38.57% in the Push-Up test, and 22.69% in the Squat test at the end of the study. The test group exhibited superior cardiovascular endurance, aerobic capacity and functional capacity as indicated by significant change of 10.29% in the VO2max, 8.41% in VO2 peak and 8.62% in 6-Minute Walk Test distance. The testosterone levels showed a difference of 10.60% between the Meet Shilajeet and Placebo group indicating that Meet Shilajeet group exhibited a noticeable improvement in the testosterone levels compared to the placebo proving its beneficial effect. Within the Meet Shilajeet group, cortisol levels exhibited a decrease of 22.96% from baseline to the end of the study. Additionally, the SF-36 assessment revealed significant improvements in Vitality (11.94%), Emotional Well-being (11.40%), Social Functioning (16.44%), and General Health (7.14%) for the Meet Shilajeet group, while the placebo group showed declines in these areas. The safet significant adverse effects reported, indicating good tolerability of the treatment. 

  
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