To study the effect of Ashwagandha capsules(300mg) on Muscle Strength and Recovery in Sports Persons
- Registration Number
- CTRI/2018/07/014969
- Lead Sponsor
- Shri Kartikeya Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female subjects with age from18 to 45 years who are sports persons
2.Willing to provide EC approved written informed consent.
3.Ability to understand the risks and benefits of the protocol
4.Subject with History of Gymnasium visit since last three months of Screening
5.Subject willing to follow the same Exercise and diet regime for study period as prescribed by the study protocol
6.Men and women of childbearing potential accepting to use adequate birth control measures, as discussed with the study doctor, until the end of study.
7.Subjects with good health as determined by:
8.Medical history
9.Physical examination
10.Clinical judgment of the investigator
11.Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)..
1.Subjects already on nutritional / Energy supplements, medication or steroids to enhance physical performance
2.Any history of drug abuse, smoking 10+ cigarettes day or consuming more than 14 grams of alcohol daily,
3.Subjects planning to participate in any Sports event during the study period
4.Weight loss of >5kg in the past 3 months
5.History of any orthopedic injury or surgery in the past 6 months
6.Participation in any clinical studies in the past 3 months
7.Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression
8.Subject with significant medication use (blood pressure, beta-blockers, inhaled beta agonists, hormonal contraceptives, corticosteroid use within prior three months, psychotropic medication use within prior eight weeks)
9.Hypersensitivity to Ashwagandha
10.Subjects with history of any prohibited drugs use
11.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in muscle strength from baseline to EOSTimepoint: 8 weeks from baseline visit
- Secondary Outcome Measures
Name Time Method a)Levels of total testosterone men/ women and free testosterone men/ women <br/ ><br>b)Muscle recovery and anthropometric factors <br/ ><br>c)Muscle size <br/ ><br>d)Endurance. <br/ ><br>Timepoint: 8 weeks from baseline visit