A Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Meet Shilajeet Supplement on Improving Vitality, Boosting stamina, Strength and Performance in Healthy Adults.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1) Queens College Step Test to determine an individual aerobic endurance.
研究概览
简要总结
This study aimed to rigorously investigate the efficacy and safety of Meet Shilajeet through a randomized, placebo-controlled clinical trial. The primary focus will be on evaluating its impact on key parameters, including energy levels, strength, stress levels, and endurance, in a cohort of healthy adults. This research is designed to provide valuable insights into the potential benefits of Shilajeet supplementation and contribute to the growing body of scientific knowledge surrounding natural interventions for health optimization. The outcomes of this research may not only have implications for individual well-being but may also inform future discussions on the integration of traditional remedies into contemporary health practices. The study demonstrated significant improvements in the Meet Shilajeet treatment group across various physical performance and health-related quality of life measures compared to the placebo group. Participants receiving Meet Shilajeet Capsules showed enhanced lower and upper body strength, as evidenced by significant improvements of 28.55% in the Sit-to-Stand test, 38.57% in the Push-Up test, and 22.69% in the Squat test at the end of the study. The test group exhibited superior cardiovascular endurance, aerobic capacity and functional capacity as indicated by significant change of 10.29% in the VO2max, 8.41% in VO2 peak and 8.62% in 6-Minute Walk Test distance. The testosterone levels showed a difference of 10.60% between the Meet Shilajeet and Placebo group indicating that Meet Shilajeet group exhibited a noticeable improvement in the testosterone levels compared to the placebo proving its beneficial effect. Within the Meet Shilajeet group, cortisol levels exhibited a decrease of 22.96% from baseline to the end of the study. Additionally, the SF-36 assessment revealed significant improvements in Vitality (11.94%), Emotional Well-being (11.40%), Social Functioning (16.44%), and General Health (7.14%) for the Meet Shilajeet group, while the placebo group showed declines in these areas. The safet significant adverse effects reported, indicating good tolerability of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male adult subjects age between 18–45 years.
- •Participants with a body mass index (BMI) of 18.5–29.9 kg/m2 3) Willing to participate in an exercise program 2-3 times per week for 8 weeks.
- •Subjects should be available for duration of study period (8 weeks).
- •Express a willingness to actively participate in the study and provide informed consent.
排除标准
- •Individuals currently undertaking resistance training exercise.
- •Clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, renal, immunological, endocrine (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
- •Taking medication with corticosteroids, antidepressants, anticholinergics, or any other drugs that may have influenced the study outcome.
- •Severe pulmonary dysfunction (uncontrolled bronchial asthma and/or chronic obstruction).
- •History of orthopaedic conditions or surgeries that would interfere with exercise performance.
- •Completed any other clinical trial within 6 months prior to enrolment.
- •Consumed any dietary supplements or herbal drugs within 7 days prior to screening.
- •Known hypersensitivity to herbal drugs, nutritional supplements, or foods.
- •Active smokers or having a history of high alcohol intake (2 standard drinks per day).
结局指标
主要结局
1) Queens College Step Test to determine an individual aerobic endurance.
时间窗: Day 0 & Day 60
2) 6 Minute Walk Test to assess aerobic capacity and endurance.
时间窗: Day 0 & Day 60
3) 30 Second Sit to Stand Test to assess functional lower extremity muscle strength and
时间窗: Day 0 & Day 60
endurance.
时间窗: Day 0 & Day 60
4) Push up test to assess upper body strength and endurance.
时间窗: Day 0 & Day 60
5) Squat Test to assess lower body strength and endurance.
时间窗: Day 0 & Day 60
6) Change in testosterone and cortisol levels from baseline to the end of the study.
时间窗: Day 0 & Day 60
次要结局
- 1) Improvement in Quality of Life (SF-36) questionnaire scores from baseline to the end of the study.(2) The change in vital signs (blood pressure, pulse rate, body temperature) from baseline to the end of the study.)
研究者
Dr Rachana K L
TrialGuna Private Limited