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A Study to Assess the Effect of Shilajit Resin on Endurance, Muscle Strength, and Body Composition in Healthy Adults

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 - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092294
Enrollment
25
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Amaara Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
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.Timepoint: 1. Baseline and Day 28 2. Baseline and day 28 3. Baseline and Day 28

Countries

India

Contacts

Public ContactMr Manoj Karwa

Amaara Ayurveda

divya.yadav@amaarabotanicals.com9560891900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026