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CTRI Number  CTRI/2025/07/091323 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the effect of TruBlk™ Shilajit Resin on improving exercise performance, endurance, muscle strength, and recovery in males. 
Scientific Title of Study   A randomized, double-blind, multicenter, placebo-controlled clinical study of TruBlk™ Shilajit Resin to evaluate the efficacy focusing on their impact in improving exercise performance, endurance, muscle strength, and recovery in males. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/021/25 Version: 1.0 Date: 25-Jun-2025  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, New Delhi, Delhi 110075

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 
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, 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  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  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Chaudhry  Aakash Healthcare Super Speciality Hospital  Room No. 20, Ground Floor, Hospital Plot, Road No. 201, Dwarka Sector-3, Dwarka, New Delhi, Delhi, 110075
South West
DELHI 		 9818444333

director@aakashhealthcare.com 
Dr Sanjay Mishra  Bensups Hospital  Ground Floor, OPD Area, Dwarka Sub-City, Sector 12, Dwarka, New Delhi, Delhi 110075
South West
DELHI 		 8527569065

sanmishra75@gmail.com 
Dr Santosh Ghai  Mata Roop Rani Maggo Hospital and IVF Centre  Room No. 07, Basement, C-8/9, Om Vihar Phase 1 Rd, opp. Metro Pillar No-709, Uttam Nagar West, Phase 1A, Delhi 110059
South West
DELHI 		 9999137803

santosh_ghai@yahoo.com 
Dr Preeti Chhabra  Shri Krishna Super Speciality Institute of Ayurveda  Room No. 01, Ground Floor, 48A, Block C4A, Janakpuri, New Delhi, Delhi, 110058
West
DELHI 		 9891008498

drpreeti.chh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Aakash Healthcare Institutional Ethics Committee   Submittted/Under Review 
GSER Independent Ethics Committee  Approved 
GSER Independent Ethics Committee  Approved 
GSER Independent Ethics Committee  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: 90 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: 250 mg of TruBlk™ Shilajit Resin consumed twice daily in morning and at evening, with 100 - 250ml of warm water.
2Comparator Arm (Non Ayurveda)-Placebo250 mg of placebo Resin consumed twice daily in morning and at evening, with 100 - 250ml of warm water.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Male participants aged between 21 to 50 years having BMI less than or equal to 30 kg per meter square.
2. Resting blood pressure averaging less than or equal to 140 or 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 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   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Changes in muscle strength (kg) assessed by 1RM on the leg press.
2. Changes in muscle endurance (repetitions) assessed by reps on the leg press.
3. Changes in the rating of perceived exertion.
4. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS). 		 1. screening, day 30, day 60, and on day 90.
2. screening, day 30, day 60, and on day 90.
3. screening, day 30, day 60, and on day 90.
4. screening, day 30, day 60, and on day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in cardiorespiratory endurance by VO2 max test by Harvard step test at screening, day 30, day 60 & on day 90.
2. Changes in percentage fat & skeletal muscle mass using BIA at screening & day 90.
3. Changes in serum total & free testosterone, CRP, & at baseline & day 90.
4. Changes in muscle damage marker Creatine kinase & LDH at baseline & day 90.
5. Changes in Hand grip strength by hand dynamometer at screening & day 90.
6. Changes in the participant & investigator global assessment score at Baseline & Day 90.
 		 1.screening, day 30, day 60 & on day 90.
2. screening & day 90.
3. baseline & day 90.
4. baseline & day 90.
5. screening & day 90.
6. baseline & day 90. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   28/07/2025 
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)  Open to Recruitment 
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 a randomized, double blind, multicenter, placebo controlled clinical study designed to evaluate the efficacy and safety of TruBlk™ Shilajit Resin in improving exercise performance, endurance, muscle strength, and recovery in healthy adult males over a 90 day period. A total of 100 male participants aged 21 to 50 years, engaged in regular resistance training, will be randomized in a equal ratio to receive either 250 mg of TruBlk™ Shilajit Resin twice daily or placebo for 90 days. The primary objective is to assess improvements in muscle strength, endurance, perceived exertion, and post exercise recovery. Secondary objectives include evaluating changes in cardiorespiratory endurance (VO2 max), testosterone levels, inflammatory marker (CRP), muscle damage markers (CK and LDH), body composition, and hand grip strength. Safety will be monitored through adverse event reporting, vital signs, and treatment compliance. The study includes 4 visits, baseline, day 30, day 60, and day 90. 
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