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 Limited0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy athletic adults of male and female subjects aged
- •between 20 and 45 years.
- •2. Subjects within the BMI range of 18.5 to 24.9 kg/m2
- •3. Subjects able to communicate effectively
- •4. Subjects willing to provide written informed consent
- •5. 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
- •5 History of severe GI disorders such as mal-absorption
- •6 History of diabetes, coronary artery disease and hypertension
- •with or without complication
- •7 History of any chronic physical, hormonal or psychiatric
- •8 Morbid Obesity (percent fat 40%
- •9 Any medical condition where exercise is contraindicated
- •10 Recent surgery or trauma which incapacitates the subject for
- •11 Currently taking any herbal preparations (other formulations
- •containing ashwagandha / ginseng / ginkgo biloba / brahmi
- •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.
研究者
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