CTRI/2018/01/011612已完成未知
A randomized, double blind, Placebo controlled, single center, study to evaluate the efficacy of herbal sports nutrition for physical endurance in healthy volunteers.
Aurea Biolabs Pvt Ltd0 个研究点目标入组 24 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
- 24
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 Male healthy adult subjects ranging in age from 18 to 55 years (both inclusive)
- •normotensive, physically active but not exercise trained.
- •2 Willingness to follow the protocol requirements as evidenced by written, informed
- •3 Agree not to use any medication including vitamins and minerals, during or before
- •the course of this study.
- •4 Subjects whose blood chemistries are within a normal range or not considered
- •clinically significant if outside the normal range.
- •5 Non smokers and non-alcoholics.
- •6 Willing to come for all follow-up visits
排除标准
- •Any clinically significant medical history, medical finding or an ongoing medical or
- •psychiatric condition exists which in the opinion of the Investigator could
- •jeopardize the safety of the subject, impact validity of the study results or interfere
- •with the completion of study according to the protocol
- •Significant abnormal findings as determined by baseline history, physical
- •examination, vital signs (blood pressure, pulse rate, respiration rate, temperature)
- •hematology, serum chemistry.
- •History of hypersensitivity reactions.
- •Smokers and alcoholics
- •History of migraine, asthma
- •Participation in a clinical study during the preceding 90 days.
- •Evidence of ischemic heart disease by history or abnormal resting or exercise
- •electrocardiogram (ECG) ( > 1mm ST segment depression), regional wall motion
- •abnormalities, left ventricular systolic dysfunction or significant valvular disease.
- •Blood or blood products donated in past 30 days prior to study supplement
- •administration.
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