CTRI/2019/12/022224招募中未知
A Randomized, Double-blind, Placebo-controlled, Parallel group, Three-arm Study to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Capsules on Improving Exercise Performance and Cardiorespiratory Endurance in Conjunction with Exercise Training in Healthy Adult Subjects.
试验速览
- 阶段
- 未知
- 状态
- 招募中
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 adult male subjects aged between 21-45 years with a BMI between 22 and 29 kg/m2.
- •2. Subjects willing to be acquainted with the gym equipment for 1-2 weeks before enrolling in
- •3. Ability to understand the risks/benefits of the protocol.
- •4. Subjects considered generally healthy as per health history and routine clinical investigations.
- •5. Subjects agree to perform physical activities as stated in the protocol in the presence of physical
- •6. Subjects should provide written informed consent and agree to be available for regular followup
- •throughout the study duration.
- •7. Subjects agree not to start any new therapies or energy boosting supplements or protein
- •supplements or health drinks during the study.
- •8. Agree to follow the dietary instructions as advised by the nutritionist during the counselling
排除标准
- •1. Subjects who are consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs. 2. Concomitant administration or history of consumption within seven (7) days prior to the screening of herbal/nutraceutical/ vitamin-minerals supplements. 3. Concomitant use of any supplement including protein/amino acids/creatine/any other product used for muscle growth/recovery/ stamina and cardiorespiratory endurance. 4. Subjects using any other therapies that would affect body composition other than those revealed during the recruitment process. 5. History or presence of any cardiovascular or bronchial / airway disease including but not limited to hypertension, myocardial infarction, coronary artery disease, cardiac failure, angina, arrhythmia, bronchial asthma. 6. Clinically significant 12- Lead ECG. 7. History or presence of any chronic systemic disorder including but not limited to endocrine, neurological, hepatic or renal disease, diabetes mellitus, stroke.
- •8. Subjects having clinically significant abnormal findings as per investigatorâ??s discretion in the hematological and biochemical laboratory tests. 9. Human immunodeficiency virus (HIV) positive subjects.10. Subjects who consume alcohol or smoke. 11. Subjects having a history or presence of psychiatric disorder. 12. Subjects with a history of any major surgical procedure within the last 6 months. 13. The subjects who have participated in a clinical study within the last 90 days before recruitment.14. Institutionalized subjects.
研究者
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