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
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvement in muscle strength from baseline to EOS
研究概览
简要总结
This is a prospective, double-blind, multi centric, randomized, placebo-controlled parallel-group study. In all, 80 (40 male and 40 female) subjects will be randomized by stratified randomization technique in order to enroll subjects in a targeted ratio of 1:1 (test: placebo). Test group and placebo group will have approximately equal number of male and female subjects. Healthy subjects who had a history of gymnasium visit in the past three months and are willing to provide written informed consent will be randomly assigned in a double-blind fashion to one of the two treatment groups. An independent third-party dispenser who is not performing clinical evaluations will dispense the blinded study medication. The IP will be administered for a period of eight weeks.
At baseline and End of Study visits, the same investigator, when possible, will assess and record the Quality of life (SF-36 questionnaire). In addition, muscle size and strength, treadmill performance, testosterone level, hematology and serum chemistry will be evaluated.
Safety will be assessed by monitoring adverse events (AEs).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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)..
排除标准
- •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.
结局指标
主要结局
Improvement in muscle strength from baseline to EOS
时间窗: 8 weeks from baseline visit
次要结局
- a)Levels of total testosterone men/ women and free testosterone men/ women(b)Muscle recovery and anthropometric factors)