A randomised, prospective, double-blind, placebo-controlled, clinical study to evaluate efficacy and safety of NRAHG001 on cardiorespiratory endurance and fatigue in healthy subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1.Change in cardiovascular endurance (VO2 max)
研究概览
简要总结
This study will be conducted to evaluate efficacy and safety of Test product, on cardiorespiratory endurance and fatigue in healthy subjects. Sufficient number of subjects will be enrolled in the study to get 60 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening visit, Visit 2 will be randomisation visit day 1. Follow up visit 3 will be on 7 ± 2 days, Follow up visit 4 will be on 28 ± 2 days, Follow up visit 5 will be on 54 ± 1 day and end of study visit will be on 56 ± 1 day. Subjects will be screened for the eligibility criteria during screening visit.
The subjects will be randomised in the ratio of 2:1 where they will either receive NRAHG001 30 mg capsule or placebo one daily in morning either before or after food for 56 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy, male and/or female adult subjects age between 18 to 45 years old (both inclusive) 2.Subjects doing physical exercise regularly almost 5 days a week for the last two years.
- •3.Subjects within body mass index (BMI) range of 18.5–24.9 kg/m
- •4.Subjects with Systolic blood pressure (SBP) less than or equal to 130 mm Hg and diastolic blood pressure (DBP) less than or equal to 89 mm Hg. 5.Subjects Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
- •Subjects who can give written informed consent and are willing to participate in the study.
排除标准
- •1.Subjects with known hypersensitivity to study product.
- •2.Subjects who have donated blood within one month before the study or have a blood hemoglobin level less than 12.0 g/dl.
- •3.Subjects with a history of any pulmonary disorder.
- •SpO2 less than 96% 6.Random blood glucose (RBG) levels greater than or equal to 140 mg/dl.
- •7.Abnormal thyroid stimulating hormone (TSH) value (less than 0.4 μIU/ml or more than 4.2μIU/ml).
- •8.Subject with a history of morbid obesity (BMI greater than 40%).
- •9.Subject with history of any medical condition where exercise is contraindicated.
- •10.Subjects who are unable to run due to any joint disorder.
- •11.History of smoking or active smokers using any form of tobacco.
- •12.Subjects who are currently on diuretics.
- •13.History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
- •14.Subjects having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
- •15.History of any significant neurological and psychiatric condition, which may affect the participation and inference of the study endpoints.
- •16.Participation in other clinical trials in the last 90 days before screening.
- •17.Subjects who are taking any nutritional supplements, medications, or steroids used to enhance physical performance.
- •19.Any planned participation in any sporting event during the study period.
结局指标
主要结局
1.Change in cardiovascular endurance (VO2 max)
时间窗: Baseline to 56 Days
次要结局
- 1. Changes in lactic acid threshold.(Baseline to 56 Days)
- 2. Changes in blood creatine phosphokinase (CPK)(Baseline to 56 Days)
- 3. Change in subjective rate of perceived exertion.(Baseline to 56 Days)
- 4. Change in neuro muscular activation.(Baseline to 56 Days)
- 5. Changes in fatigue level.(Baseline to 56 Days)
- 6. Adverse events(Baseline to 56 Days)
研究者
Dr Milan Satia
Ethicare Clinical Trial Services