CTRI/2016/05/006950已完成未知
Efficacy and Safety of a Novel herbal composition LI12542F6 in improvement of Muscular Energy, Endurance and Muscle Strength in Resistance trained Healthy Male Subjects: A Randomized, Double-Blind, Placebo-Controlled Study.
aila Nutraceuticals0 个研究点目标入组 40 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
- 40
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
- •Male subjects between 18-40 years of age.
- •Ability to understand the risks/benefits of the protocol.
- •Subjects familiar with weight training and have at least 6 months experience with 4 times per week for at least 3 to 4 hours (Recreational athletes).
- •Agree to do physical activities as stated in the protocol in presence of physical trainer.
- •Willingness to participate in an exercise program (4 days a week, during the course of the study).
- •Subjects should be available for entire duration of study period (8 weeks).
- •Ready to refrain from exercise for 2 days before the baseline evaluation.
- •Subject agrees not to consume any supplement which would affect body composition during the entire course of the study.
- •Subjects agree to maintain the activity diary.
- •Willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •No contraindications to exercise as outlined by the American College of Sports Medicine (ACSM).
- •Use of nutritional supplements known to improve energy and muscle strength and/or muscle mass (e.g., Creatine, HMB, androstenedione, DHEA, etc.) within seven weeks prior to the start of the study.
- •All medications that can interfere with muscle mass such as corticosteroids (e.g. Prednisone), testosterone replacement or anabolic drugs.
- •Subjects who are under herbal supplements within seven (7) days prior to screening.
- •Subjects using any other therapies that would affect body composition other than those revealed during recruitment process.
- •Subjects having history of cardiovascular or respiratory disorders.
- •Subjects having history of Diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose >= 140-199 mg/dl.
- •Subjects having thyroid disease.
- •Subjects having abnormal liver or kidney function parameters (ALT or AST 2 times the upper limit of normal; elevated Creatinine, males 125 µmol/L).
- •Subjects having abnormal findings on complete blood count
- •Subjects with HIV Positive.
- •Subjects having history of high alcohol intake (2 standard drinks per day).
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
- •Subjects participated in any clinical study within thirty (30) days prior to screening visit.
研究者
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