A randomized, double-blind, placebo-controlled clinical study of Shilajit gummies to evaluate the efficacy focusing on their impact on energy levels, fatigue reduction, and muscle mass increase in males.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Changes in muscle strength using a standard plate loaded leg press and chest press machine, Rep max for leg press and chest press at screening and day 60.
研究概览
简要总结
The rationale for this formulation lies in the synergistic interaction of Shilajit, Ashwagandha, Ginger, Black Pepper, Mucuna Pruriens, and Akarkara, all of which have scientifically proven benefits in enhancing muscle strength, endurance, testosterone levels, and post-exercise recovery. The proposed clinical trial will use a randomized, double-blind, placebo-controlled design to rigorously evaluate the efficacy of this formulation in healthy adults engaged in regular physical activity.
Shilajit, the core ingredient, is rich in fulvic acid and essential minerals, enhancing mitochondrial function and ATP production. Studies have demonstrated its ability to increase endogenous testosterone levels and support muscle recovery by reducing oxidative stress and inflammation. These effects are crucial for improving overall physical performance, especially in exercise-induced fatigue.
Ashwagandha, a potent adaptogen, has been extensively studied for its ability to increase VO2max, reduce cortisol, and promote muscle strength and endurance. Research shows that it supports post-exercise recovery by modulating the hypothalamic-pituitary-adrenal axis, reducing stress, and improving muscle repair.
Ginger’s anti-inflammatory and antioxidant properties help reduce muscle soreness, while Mucuna Pruriens, through its L-DOPA content, stimulates dopamine production, supporting testosterone synthesis and muscle hypertrophy. Black Pepper enhances the bioavailability of these active compounds, ensuring maximum absorption and efficacy. Akarkara, a lesser-known traditional herb, has shown promise in enhancing physical strength and vitality.
This scientifically driven formulation aims to optimize muscle recovery, enhance physical performance, and boost testosterone levels. By conducting a well-designed randomized controlled trial, this study will provide robust evidence to support the use of this combination in improving muscle strength, endurance, and recovery in physically active individuals.
The study has completed and the data is available with the sponsor of the study on individual request basis.
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 per m2;2.Resting blood pressure averaging less than 140 by 90 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 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 which proves participant unfit for the study participation; 6.Any known cardiovascular or metabolic disease; 7.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation; 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
1.Changes in muscle strength using a standard plate loaded leg press and chest press machine, Rep max for leg press and chest press at screening and day 60.
时间窗: Screening, day 30 and day 60
2.Changes in muscle endurance using a standard plate loaded leg press and chest press machine by measuring Reps to fatigue at 50 percent 1 Rep Max at screening and day 60.
时间窗: Screening, day 30 and day 60
3.Changes in hypertrophy measurements of at three sites that is arm (flexed mid upper arm), chest (sternum at mid tidal volume) and upper thigh (just inferior to gluteal fold) (in cm) at screening and day 60.
时间窗: Screening, day 30 and day 60
4.Changes in the rating of perceived exertion at screening, day 30 and day 60. Modified to encompass the entire training day. 1 to 10 scale as to how hard that workout was. The higher the scale score, the harder the workout felt to the participant.
时间窗: Screening, day 30 and day 60
5. Assessment of changes in recovery from exercise Post Delayed onset muscle soreness (DOMS),48 hours at screening, day 30 and day 60.
时间窗: Screening, day 30 and day 60
次要结局
- 1.Changes in serum total testosterone, free testosterone levels & cortisol levels at screening & day 60.(2.Changes in muscle damage markers creatine kinase (CK), at Pre Exercise Bout, Immediate Post Exercise Bout & 24 Hours Post-Exercise Bout at screening & day 60.)
研究者
Dr Ketan Kshirsagar
Sangvi Multispeciality Hospital Pvt. Ltd