None listed
Conditions
Interventions
Intervention1: KSM-66 Ashwagandha (Withania Somnifera): 300 mg twice daily orally with Milk/water in morning and Night for a period of 8 weeks
Control Intervention1: Placebo: 300 mg twice daily oral
Sponsors
Shri Karthikeya Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in VO2 Max : Cooper 12 min run test from the baseline to last visit 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 Improvement in oxidative stress by assessment of free radicals Timepoint: Improvement in VO2 Max : Cooper 12 min run test from the baseline to last visit 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 Improvement in oxidative stress by assessment of free radicals | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Safety 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. Timepoint: for a period of 8 weeks from randomization | — |
Countries
India
Contacts
Public ContactPawan Bhusari
Shre Karthikeya Pharma
Outcome results
None listed