A Randomized Double Blind Placebo Controlled Comparative Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) Capsules 300 mg on Muscle Strength and Recovery in Sports Persons - KSM-66/PMS/2017/01,v1.1

Shri Kartikeya Pharma0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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