CTRI

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CTRI Number

CTRI/2025/02/080309 [Registered on: 10/02/2025] Trial Registered Prospectively

Last Modified On:

28/03/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Effects of Shilajit Resin on Exercise Performance and Recovery in Males.

Scientific Title of Study
Modification(s)

A randomized, double-blind, placebo-controlled clinical study of TruBlkTM Shilajit Resin to evaluate the efficacy focusing on their impact on improving exercise performance, endurance, muscle strength, and recovery in males.

Trial Acronym

NIL

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
MHC/CT/24-25/053 Version: 2.00; Dated, 21 February 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ramshyam Agarwal
Designation	Principal Investigator
Affiliation	Lokmanya Medical Research Centre and Hospital
Address	Room No 401314 Fourth floor B Telco Road Chinchwad - Pune MAHARASHTRA 411033 India
Phone	8087282022
Fax	-
Email	ramshyam.research@gmail.com

Details of Contact Person
Scientific Query

Name	Divya Yadav
Designation	Founder
Affiliation	Amaara Ayurveda
Address	Office No 64 Sector 6 IMT Manesar Gurgaon - South West DELHI 122050 India
Phone	9560891900
Fax	-
Email	divya.yadav@amaarabotanicals.com

Details of Contact Person
Public Query

Name	Amandeep Singh
Designation	Founder and CEO
Affiliation	Amaara Ayurveda
Address	Office No 64 Sector 6 IMT Manesar Gurgaon - South West DELHI 122050 India
Phone	8769610100
Fax	-
Email	amandeep.singh@amaarabotanicals.com

Source of Monetary or Material Support

Amaara Ayurveda Plot No. 64, Sector-6, IMT Manesar, Gurgaon India 122050.

Primary Sponsor

Name	Amaara Ayurveda
Address	Plot No. 64, Sector-6, IMT Manesar, Gurgaon India 122050.
Type of Sponsor	Other [Manufacturer and Exporter of Ayurvedic Extract]

Details of Secondary Sponsor

Name	Address
NIL	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 Ramshyam Agarwal	Lokmanya Medical Research Centre and Hospital	Room No 401 314 Fourth floor B Telco Road Chinchwad Pune MAHARASHTRA	8087282022 - ramshyam.research@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 2
Name of Committee	Approval Status
Lokmanya Medical Research Centre	Approved
Lokmanya Medical Research Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Adults

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: (TruBlkTM 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: with one cup (100-250 mL) of warm water on an empty stomach in the morning and at bedtime.
2	Comparator Arm	Drug	Classical		(1) Medicine Name: (Placebo), 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: with one cup (100-250 mL) of warm water on an empty stomach in the morning and at bedtime.

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/m2 2.Resting blood pressure averaging less than 140 per90 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 investigator 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, creatine, 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
Modification(s)

Outcome	TimePoints
The primary objective of this study will be to assess the effectiveness of TruBlk TM Shilajit Resin compared to a placebo in enhancing muscle strength, muscle endurance, hypertrophy, perceived exertion, body fat percentage, skeletal muscle mass, and post-exercise recovery in adult males over 90 days.	1.At screening Day 30,60 and Day 90

Secondary Outcome
Modification(s)

Outcome

TimePoints

1.Changes in cardiorespiratory endurance by VO2 max test by Howard step test
2.Changes in anthropometric parameters body weight (kg), BMI (Kg/m2) .
3.Changes in serum-free testosterone, CRP, & fasting blood glucose levels .
4.Changes in muscle damage marker Creatinine kinase & LDH at 24 Hours Post-Exercise Bout (On 10 patients per group).
5.Changes in Hand grip strength by hand dynamometer
6.Changes in the gastrointestinal symptom rating scale (GSRS) score

1.at screening, day 30, 60 & 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

Phase 2

Date of First Enrollment (India)

21/02/2025

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)

Not Yet Recruiting

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

Shilajit, a natural mineral-rich resin, possesses potential androgenic properties, promoting hypertrophy and enhancing exercise performance. By supporting muscle growth and improving energy utilization, Shilajit may contribute to enhanced cardiac performance.

This randomized, double-blind, placebo-controlled study aims to assess the efficacy of Shilajit resin in improving exercise performance, endurance, muscle strength, and recovery in males. Shilajit, a natural compound rich in fulvic acid, trace minerals, and bioactive substances, has shown promise in enhancing testosterone levels, reducing oxidative stress, and improving mitochondrial function. These properties may contribute to increased muscle strength, stamina, and faster recovery following intense physical activity. Shilajit resin in improving sexual health in middle-aged adult males.