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CTRI Number  CTRI/2025/08/092294 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A Study to Assess the Effect of Shilajit Resin on Endurance, Muscle Strength, and Body Composition in Healthy Adults 
Scientific Title of Study   An Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Shilajit Resin on Endurance, Muscle Performance, and Body Composition in Healthy Adults 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/026/25 Version 1.0 Dated 18-Jul-2025 Page  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Mishra 
Designation  Principal Investigator 
Affiliation  Bensups Hospital 
Address  Bensups Hospital, Ground Floor, OPD Area, Dwarka Sub-City, Sector 12, Dwarka, NewDelhi, Delhi 110075 South West DELHI 110075 India

South West
DELHI
110075
India 
Phone  8527569065  
Fax    
Email  sanmishra75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divya Yadav 
Designation  Founder 
Affiliation  Amaara Ayurveda 
Address  Amaara Ayurveda Plot No. 63 and 64, Sector 6, IMT Manesar, Gurugram, Haryana 122050,India Gurgaon HARYANA 122050 India

Gurgaon
HARYANA
122050
India 
Phone  9560891900  
Fax    
Email  divya.yadav@amaarabotanicals.com  
 
Details of Contact Person
Public Query  
Name  Mr Manoj Karwa 
Designation  Head Clinical Trial & Pharmacovigilance 
Affiliation  Auriga Research Private Limited 
Address  Auriga Research Private Limited Plot No. 136, Sector 5, IMT Manesar, Gurugram, Haryana122050, India Gurgaon HARYANA 122050 India

Gurgaon
HARYANA
122050
India 
Phone  9313367656  
Fax    
Email  manojkarwa@aurigaresearch.com  
 
Source of Monetary or Material Support  
Amaara Ayurveda, Plot No. 63 & 64, Sector-6, IMT Manesar, Gurugram, Haryana – 122050, India 
 
Primary Sponsor  
Name  Amaara Ayurveda 
Address  Amaara Ayurveda, Plot No. 63 & 64, Sector-6, IMT Manesar, Gurugram, Haryana – 122050, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Mishra  Bensups Hospital  Ground Floor, OPD Area, DwarkaSub-City, Sector 12, Dwarka,New Delhi, Delhi 110075 South West DELHI
South West
DELHI 		 8527569065

sanmishra75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GSERIndependentEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adults 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: TruBlk™ Shilajit Resin, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Warm Water)), Additional Information: 250 mg of TruBlk™ Shilajit Resin consumed twicedaily in morning and at evening, with 100 - 250mlof warm water.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  1. Male participants aged between 21 to 55 years having BMI less than or equal to 30 kg per meter square.
2. Engaged in regular resistance training (comprising of cardio and strength training) and willing to continue the same during the study.
3. Not on any medication for cardiovascular and metabolic disorders.
4. Willing to maintain their routine diet and physical activity levels throughout the study.
5. Willing and able to provide written informed consent and comply with study procedures. 
 
ExclusionCriteria 
Details  1. Participants with any acute illness requiring immediate medical care.
2. Participants with any chronic medical condition.
3. Participants with a 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 investigators discretion.
5. Any other condition that proves the participant unfit for the study participation.
6. Any known cardiovascular or metabolic disease
7. Participants who are currently taking any herbal supplements, nutraceuticals, creatinine, anabolic steroids, testosterone boosters, or non prescribed medications that may impact muscle growth, endurance, or testosterone levels (with the exception of protein supplements).
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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Changes in muscle strength (kg) assessed by 1RM on the leg press at baseline, Day 14 and Day 28.
2. Changes in muscle endurance assessed by reps on the leg press after 1RM at baseline, Day 14 and Day 28.
3. Changes in the rating of perceived exertion at baseline, Day 14 and Day 28.
4. Changes in recovery from exercise Post Delayed onset muscle soreness (DOMS), (defined as aching pain and soreness in a given muscle post 48 hours of exercise) at baseline, Day 14 and Day 28.
5. Change in Fatigue levels assessed using Fatigue Severity Scale (FSS) at baseline, Day 14 and Day 28.
6.Change in isometric muscle strength (dominant and non-dominant hand) using a hand dynamometer at baseline and Day 28. 		 1. Baseline, Day 14 and Day 28
2. Baseline, Day 14 and Day 28
3. Baseline, Day 14 and Day 28
4. Baseline, Day 14 and Day 28
5. Baseline, Day 14 and Day 28
6. Baseline and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in body composition (lean body mass, fat mass) as measured by Body Composition Analyser (BCA) at baseline and Day 28.
2. Changes in cardiorespiratory endurance by VO2 max test by using modified Harvard step test at baseline and day 28.
3. Changes in serum levels of Total Testosterone, lactate dehydrogenase (LDH), Creatine Kinase (CK) and C-reactive protein (CRP) at baseline and Day 28. 		 1. Baseline and Day 28
2. Baseline and day 28
3. Baseline and Day 28 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   14/08/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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   This is an open label single arm interventional pilot study designed to evaluate the efficacy and safety of TruBlk™ Shilajit Resin 250 mg twice daily in improving muscle endurance strength fatigue and body composition in healthy physically active adult males aged 21 to 55 years A total of 25 participants will receive the investigational product over a 28 day period Primary endpoints include changes from baseline in 1RM leg press strength endurance repetitions perceived exertion Delayed Onset Muscle Soreness recovery fatigue severity and isometric handgrip strength Secondary assessments include changes in body composition VO2 max and serum biomarkers Testosterone CK LDH CRP Safety will be monitored through adverse events vitals and laboratory parameters. 
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