Clinical Study to Evaluate the Efficacy and Safety in Healthy Adults for a period of 2 months for the safety endpoints.
- Registration Number
- CTRI/2024/05/066815
- Lead Sponsor
- Herbal Creations
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method