A study to evaluate effiacy and safety of KSM-66 Ashwagandha (Withania somnifera) on improving cardiorespiratory endurance in healthy athletic adults
- Registration Number
- CTRI/2012/05/002670
- Lead Sponsor
- SKP Labs Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Healthy athletic adults of male and female subjects aged
between 20 and 45 years.
2. Subjects within the BMI range of 18.5 to 24.9 kg/m2
3. Subjects able to communicate effectively
4. Subjects willing to provide written informed consent
5. In the judgment of the Principal Investigator, able to
comply with protocol requirements
1 Contraindications or Hypersensitivity to ashwagandha and
related herbal products.
2 History or presence of any medical condition or disease
according to the discretion of the Investigator.
3 History of significant renal or hepatic problems.
4 History of significant asthma, urticaria or other allergic
reactions
5 History of severe GI disorders such as mal-absorption
syndrome.
6 History of diabetes, coronary artery disease and hypertension
with or without complication
7 History of any chronic physical, hormonal or psychiatric
illness
8 Morbid Obesity (percent fat 40%
9 Any medical condition where exercise is contraindicated
10 Recent surgery or trauma which incapacitates the subject for
exercise.
11 Currently taking any herbal preparations (other formulations
containing ashwagandha / ginseng / ginkgo biloba / brahmi
etc).
12 Current substance dependence
13 Individuals refusing to use appropriate non-hormonal birth
control measures.
14 Subjects participating in any other trial.
15 Female subjects found positive in urine pregnancy test.
16 Female subjects who are under breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in the 20M shuttle run test score from Visit 0 to after <br/ ><br>Day 56 (Visit 2) and Day 84 (Visit 3) of treatment.Timepoint: day 0, day 28, day 84
- Secondary Outcome Measures
Name Time Method Safety will be assessed from the number of adverse events <br/ ><br>occurred and judging their causal relationship to the study drug. <br/ ><br>â?? The change in the Borg scale score, after Visit 0 to after Day 56 <br/ ><br>(Visit 2) and Day 84 (Visit 3) of treatment. <br/ ><br>â?? Quality of life (QOL) of improvement.Timepoint: day 0 day 28, day 56, day 84