Effect of KSM66 Ashwagandha (Withania somnifera) on Muscle Strength, Endurance and Recovery during Resistance Exercise in Healthy Male Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement from baseline in the muscular strength and endurance after 8 weeks
研究概览
简要总结
This studyis A prospective, randomized, double-blind, placebo-controlled study to assessthe Effect of KSM66 Ashwagandha (Withania somnifera) on muscle strength,endurance and recovery during resistance exercise in healthy male adults.A total of50 healthy male volunteers will be recruited in this study with 25 in each ofthe two treatment groups. Adult male or female subjects between 18 to 50 yearsof age, with physical training activity or gymnasium activity of at least 5hours in a week, willing to restrain from alcohol and smoking during the studyperiod and agree to abide by the studyactivities, requirements and restrictions and willing to return for therequired assessments will beenroll in study. Study duration will be 8 weeks for each subject with baseline,week 4 & week 8 visits. Subjects were asked to take 1 capsule two timesdaily (total 2 capsules per day) with water daily for 8 weeks. At the end ofstudy primary outcome will be assessed as Improvement frombaseline in the muscular strengthand endurance and secondary outcomeas improvement from baseline in musclesize, body composition, muscledamage and Changes in serum testosterone after therapy. Safety will be assessed by evaluation of adverseevents reported by the patients during the study and Global assessment oftolerability will be performed by physician at the end of study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Adult males between 18 – 50 years of age 2.Subjects with physical training activity or gymnasium activity of at least 5 hours in a week 3.Subjects willing to restrain from alcohol and smoking during the study period 4.Subjects have the ability to understand the requirements of the study 5.Subjects agree to abide by the study activities, requirements and restrictions and willing to return for the required assessments 6.Subjects willing to sign informed consent.
排除标准
- •1.Females 2.Subjects taking any medication, drugs, steroids or protein supplements (excluding regular dietary protein) in any form to enhance the physical performance 3.Subjects with active weight loss of >5 kg in past 3 months (intended or unintended 4.Subject has a history of medical or surgical events that may affect the study outcome or place the subject at risk, including cardiovascular disease, gastrointestinal problems, metabolic, renal, hepatic, neurological or active musculoskeletal disorders 5.Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day) 6.history of regular alcohol intake i.e. with atleast one alcoholic beverage (14gm/day) per day (‘regular drinkers’) 7.Subjects with a history of any drug dependence or substance abuse 8.Subjects with known hypersensitivity to Ashwagandha 9.Subject with a history of any orthopedic injury within the past 6 months 10.Subjects with a history of any major surgery within the past 6 months 11.Participation in other clinical study during previous 3 months 12.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
结局指标
主要结局
Improvement from baseline in the muscular strength and endurance after 8 weeks
时间窗: 8 weeks
次要结局
- Improvement in the body composition from baseline using BIA(8 weeks)
- Change in the serum testosterone(8 weeks)
- •Improvement from baseline in the muscle damage during resistance exercise analyzed by measuring the serum creatinine kinase (CK) 24 hours after the exercise(8 weeks)
- Improvement in the Muscle size from baseline(8 weeks)