A Randomized, Double Blind, Placebo Controlled, Parallel Treatment Clinical Study to Evaluate the Safety and Effects of ProlanzaTM (Ashwa SR) 300 mg Capsules on Muscle Strength in Recreationally Active Healthy Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in muscle strength in 1-RM of bench press load
研究概览
简要总结
Physical fitness, particularly muscle strength and cardiorespiratory endurance, is a key predictor of long-term health, reducing the risk of chronic diseases and premature death. Muscle endurance, which is linked to muscle strength, plays a crucial role in overall fitness and systemic health. VO2 max, a measure of cardiorespiratory endurance, reflects the body’s ability to utilize oxygen during intense exercise. Non-compliance to fitness regimens, particularly resistance training, can hinder progress, but adaptogens like Ashwagandha (Withania somnifera) may improve physical adaptability to exercise. Known for its various health benefits. This herb has been studied as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardioprotective, thyroid modulating, immunomodulating, antibacterial, antifungal, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic properties. Ashwagandha contains a range of bioactives like withanolides, sitoindosides and other alkaloids that are pharmacologically and medicinally important. These protect the cells from oxidative damage and disease.It is also known for its various health benefits. including enhancing energy, endurance, and vitality, Ashwagandha is believed to help improve muscle strength and endurance by reducing stress. The current study aims to assess the safety and effectiveness of Ashwa SR 300 mg capsules in improving muscle strength, endurance, and serum testosterone levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged between 25-50 years (both inclusive) who are recreationally active and gym going subjects who are at the initial stages of their strength training (less than 1 month).
- •Subjects within the BMI range of 25.0 to less than 29.9 kg/m².
- •Healthy subjects as determined by: Medical history, Physical examination, and clinical judgment of the investigator.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy
- •Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
- •Subjects who are not dependent on tobacco products alcohol consumption or any other substance abuse and are agreeing to refrain from alcohol, tobacco products and other substances of abuse during the study.
- •Subjects who agree to refrain from any kind of supplements (protein and metabolism supplements, steroids etc) that enhance muscle strength and performance.
- •Subjects who agree to maintain normal diet without any major amplifications or modifications during the study.
- •Subjects who agree to be consistent with their workout regimen (must attend the gym/fitness session for 5 continuous days of a 7-day week with alternating days of resistance training and aerobic training culminating with 2 days of rest) and willing to include bench press, leg extension and treadmill in their regimen.
- •Subjects who agree to abide by the conditions of the study protocol and are willing to sign the informed consent and comply with study procedure.
排除标准
- •Subjects younger than 25 years or older than 50 years.
- •Female subjects who are pregnant, breast-feeding or who are planning to become pregnant during the study.
- •Subject with hypersensitivity to any of the ingredients of the study products.
- •Subjects with any significant uncontrolled systemic illness (including but not limited to uncontrolled hypertension, chronic renal disease, chronic liver disease, poorly controlled diabetes mellitus, congestive heart failure, coronary artery disease, STDs, musculoskeletal disorders etc.).
- •Concurrent use of supplements for stress/anxiety/sleep/any other indications, herbal or pharmaceutical preparations.
- •Subjects who are concurrently using medication or steroids to enhance physical performance.
- •Subjects who are on any medication/treatment for infertility/enhancement of sexual function within 6 months prior to study enrolment.
- •Subjects who are alcohol dependent.
- •Subjects who are inconsistent with their workout regimen.
- •Subjects with a weight loss of more than 5 kg in the previous 3 months,
- •Subjects with any history of drug abuse, smoking cigarettes or consuming any tobacco products or alcohol.
- •Subjects with history of any orthopedic injury or surgery within the previous 6 months,
- •Participation in other clinical studies during the previous 3 months.
- •Difficulty in swallowing and retaining oral formulation.
- •Subjects who are not willing or unable to provide blood samples for study related evaluations.
- •Any condition that in opinion of the Investigator, does not justify the Subjects’ participation in the study.
结局指标
主要结局
Change in muscle strength in 1-RM of bench press load
时间窗: baseline to day 91
次要结局
- Comparison of change between Ashwa SR 300 mg and placebo groups for following parameters:(• Muscle strength from baseline to day 30, and 60 in 1-RM of bench press load.)
研究者
Dr Girish H Rudrappa
Rajalakshmi Hospital and Research Center