A randomized, double-blind, placebo-controlled clinical study of TruBlkTM Shilajit Resin to evaluate the efficacy focusing on their impact on improving exercise performance, endurance, muscle strength, and recovery in males.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary objective of this study will be to assess the effectiveness
研究概览
简要总结
Shilajit, a natural mineral-rich resin, possesses potential androgenic properties, promoting hypertrophy and enhancing exercise performance. By supporting muscle growth and improving energy utilization, Shilajit may contribute to enhanced cardiac performance.
This randomized, double-blind, placebo-controlled study aims to assess the efficacy of Shilajit resin in improving exercise performance, endurance, muscle strength, and recovery in males. Shilajit, a natural compound rich in fulvic acid, trace minerals, and bioactive substances, has shown promise in enhancing testosterone levels, reducing oxidative stress, and improving mitochondrial function. These properties may contribute to increased muscle strength, stamina, and faster recovery following intense physical activity. Shilajit resin in improving sexual health in middle-aged adult males.
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 40.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male participants aged between 18-40 years having BMI less than 35 kg/m2 2.Resting blood pressure averaging less than 140 per90 mmHg 3.Not on any medication for cardiovascular and metabolic disorders 4.Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study 5.Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator 6.Willing to provide consent and come for regular follow-up visits.
排除标准
- •1.Participants with any acute illness requiring immediate medical care; 2.Participants with any chronic medical condition; 3.Participants with a sedentary lifestyle not able or not advised to undergo the resistance training as per protocol; 4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion; 5.Any other condition that proves the participant unfit for the study participation; 6.Any known cardiovascular or metabolic disease; 7.Participants who are currently taking any herbal supplements, nutraceuticals, creatine, anabolic steroids, testosterone boosters, or non-prescribed medications that may impact muscle growth, endurance, or testosterone levels (with the exception of protein supplements); 8.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
结局指标
主要结局
The primary objective of this study will be to assess the effectiveness
时间窗: 1.At screening Day 30,60 and Day 90
of TruBlk TM Shilajit Resin compared to a placebo in enhancing muscle
时间窗: 1.At screening Day 30,60 and Day 90
strength, muscle endurance, hypertrophy, perceived exertion, body fat
时间窗: 1.At screening Day 30,60 and Day 90
percentage, skeletal muscle mass, and post-exercise recovery in adult
时间窗: 1.At screening Day 30,60 and Day 90
males over 90 days.
时间窗: 1.At screening Day 30,60 and Day 90
次要结局
- 1.Changes in cardiorespiratory endurance by VO2 max test by Howard step test(2.Changes in anthropometric parameters body weight (kg), BMI (Kg/m2) .)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital