CTRI/2016/06/007017已完成未知
A randomized, pilot, double blind, placebo controlled cross-over human study to evaluate the efficacy of oxystorm on physical endurance in healthy volunteers
Arjuna Natural Extracts Ltd0 个研究点目标入组 12 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
- 12
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 a B.W in between 45 to 75 kg.
- •2. Subject is a non-smoker.
- •3. Subject is in good health and appropriate for exercise.
- •4. Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
- •5. Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion.
- •6. Subject is willing and able to comply with the protocol including:
- •Attending 4 visits each of which is approximately 3 hours long;
- •Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits;
- •Refraining from physical training or exercise for the 48 hours prior to the test visits;
- •Refraining from taking any dietary or herbal supplements throughout the study.
- •7. Subject is able to understand and sign the informed consent to participate in the study.
排除标准
- •The subjects will be excluded based on the following criteria during screening and during the study.
- •1. Subjects with or prior history or presence of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
- •3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- •4. No prescription or chronic medication use allowed without PI discretion.
- •5. Subject has an allergy to any of the ingredients in the test product.
- •6. Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/ supplements; seven-day washout required for study inclusion.
- •7. Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine; seven-day washout required for study inclusion.
- •8. Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day.
- •9. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination.
- •10. Subject has a history of drug or alcohol abuse in the past 12 months.
- •11. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
研究者
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