Clinical study to study the efficacy and safety of KSM- 66 Ashwagandha (Withania Somnifera) cardiac endurance and Oxidative Stress in Athletes / Sports persons
- Registration Number
- CTRI/2016/04/006791
- Lead Sponsor
- Shri Karthikeya Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Male and female subjects above 18 to 45 years of age who are Football/Hockey Players / Body builders/ Athletes and willing to give written informed Consent
Subjects within the body mass index (BMI) range of 18.5 to 24.9 kg/m2
Ability to understand the risks and benefits of the protocol
Subject ready to refrain from Alcohol and Smoking during the study period
•Subject with Medical History Interfering with the results
•Subjects already on nutritional / Energy supplements
•Subjects planning to participate in any Sports event during the study period
•Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression;
•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;
•Subjects with history of any prohibited drugs
•Subject with Known hypersentivity to Ashwagandha( WS) or any other herbal products
•Individuals refusing to use appropriate non hormonal birth control measures
•Female subjects who were pregnant or breast feeding.
•Subjects participating in any other trial
•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 VO2 Max : Cooper 12 min run test from the baseline to last visit <br/ ><br>Improvement fatigue estimation as per The Recovery â?? Stress Questionnaire for athletes (REST-Q-Sport, Daily Analysis of Life Demands for Athletes (DALDA), and the Total Recovery Scale (TQR) by 2 scores from baseline to last visit <br/ ><br>Improvement in oxidative stress by assessment of free radicals <br/ ><br>Timepoint: Improvement in VO2 Max : Cooper 12 min run test from the baseline to last visit <br/ ><br>Improvement fatigue estimation as per The Recovery â?? Stress Questionnaire for athletes (REST-Q-Sport, Daily Analysis of Life Demands for Athletes (DALDA), and the Total Recovery Scale (TQR) by 2 scores from baseline to last visit <br/ ><br>Improvement in oxidative stress by assessment of free radicals <br/ ><br>
- Secondary Outcome Measures
Name Time Method Clinical Safety <br/ ><br>Adverse events will be reported and classified as to their type, severity and relationship to medication. Any changes in laboratory parameters will also be reported. <br/ ><br>Timepoint: for a period of 8 weeks from randomization