CTRI/2012/05/002670已完成3 期
A Randomized, Prospective, Double Blind, Placebo Controlled Study to Evaluate Efficacyand Safety of KSM-66 Ashwagandha (Withania somnifera) on Improving CardioRespiratory Endurance in Healthy Athletic Adults
SKP Labs Private Limited1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in the 20M shuttle run test score from Visit 0 to after
研究概览
简要总结
This is a randomized, parallel-group, double-blind, placebo-controlled
study to evaluate the efficacy and safety of KSM-66 ashwagandha on
cardio respiratory endurance in healthy athletic adults. The efficacy will be assessed by using 20M shuttle run test (Vo2 max), Borg scale Test and QOL questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy athletic adults of male and female subjects aged between 20 and 45 years.
- •Subjects within the BMI range of 18.5 to 24.9 kg/m2
- •Subjects able to communicate effectively
- •Subjects willing to provide written informed consent
- •In the judgment of the Principal Investigator, able to comply with protocol requirements.
排除标准
- •1 Contraindications or Hypersensitivity to ashwagandha and related herbal products.
- •2 History or presence of any medical condition or disease according to the discretion of the Investigator.
- •3 History of significant renal or hepatic problems.
- •4 History of significant asthma, urticaria or other allergic reactions 5 History of severe GI disorders such as mal-absorption syndrome.
- •6 History of diabetes, coronary artery disease and hypertension with or without complication 7 History of any chronic physical, hormonal or psychiatric illness 8 Morbid Obesity (percent fat 40% 9 Any medical condition where exercise is contraindicated 10 Recent surgery or trauma which incapacitates the subject for exercise.
- •11 Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc).
- •12 Current substance dependence 13 Individuals refusing to use appropriate non-hormonal birth control measures.
- •14 Subjects participating in any other trial.
- •15 Female subjects found positive in urine pregnancy test.
- •16 Female subjects who are under breast feeding.
结局指标
主要结局
The change in the 20M shuttle run test score from Visit 0 to after
时间窗: day 0, day 28, day 84
Day 56 (Visit 2) and Day 84 (Visit 3) of treatment.
时间窗: day 0, day 28, day 84
次要结局
- Safety will be assessed from the number of adverse events(occurred and judging their causal relationship to the study drug.)
研究者
研究点 (1)
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