None listed
Conditions
Interventions
Intervention1: KSM-66 Ashwagandha (withania Somnifera: KSM66 300mg capsules
twice daily (morning & evening)
Orally
Control Intervention1: Placebo: Placebo capsules 300mg
twice daily (morning & even
Sponsors
Shri Kartikeya Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 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)..
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in muscle strength from baseline to EOSTimepoint: 8 weeks from baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Levels of total testosterone men/ women and free testosterone men/ women b) Muscle recovery and anthropometric factors c) Muscle size d) Endurance. Timepoint: 8 weeks from baseline visit | — |
Countries
India
Contacts
Public ContactPawan Bhusari
Shri Karthikeya Pharma
Outcome results
None listed