None listed
Conditions
Interventions
Intervention1: Meet Shilajeet: Route of Administration: Oral
dosage Quantity: Meet Shilajeet supplement 500 mg capsule
Twice a day treatment for 2 months
Control Intervention1: Microcrystalline cellu
Sponsors
Herbal Creations
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 0 & Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 0 & Day 60 | — |
Countries
India
Contacts
Public ContactMeena Dalal
TrialGuna Private Limited
Outcome results
None listed