CTRI/2022/06/043370已完成未知
A randomized, double-blind, placebo controlled, clinical study to measure the effect of natural phytochemical formulation on muscle fatigue, endurance energy supply, recovery and neuro muscular activation in delayed onset muscle soreness (DOMS), and related inflammation and stress in healthy untrained subjects.
AureaBiolabs Private Limited0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 110
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) Subject has provided written, signed and dated informed consent to
- •participate in the study.
- •2) Subject is willing and able to comply with the protocol,
- •3) Male or female subjects between 19-50 years of age (both inclusive).
- •4) Subjects should be untrained as defined by, less active that is regular exercise for less than 4 h per week.
- •5) Subject is in good health as determined by a health history and as per
- •Investigator discretion.
- •6) Subject is untrained in resistance/power exercise.
排除标准
- •1) Subject is participating in another clinical trial or has received an
- •investigational product within thirty days prior to enrollment.
- •2) Subject has a history of alcohol or other drug abuse in the past year.
- •3) Subject has a significant history or current presence of treated or
- •untreated bleeding disorder, diabetes mellitus, high blood pressure
- •(BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease,
- •tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •4) Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •5) Subject has a known allergy or sensitivity to any ingredient in the test product.
- •6) Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •7) Subject has a history of difficulty swallowing large pills or tablets.
- •8) Subject has used creatine within 9 weeks prior to screening.
- •9) Subject has a history of orthopedic injury or surgery within the last
- •10) Subject has any physical condition considered a contraindication to the type of exercise performed in the study.
- •11) Subject has had an abnormal resting ECG.
- •12) Investigator is uncertain about subjectâ??s capability or willingsness to comply with the protocol requirments.
研究者
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