Study of Ashwagandha (Withania somnifera) on Muscle Strength, Endurance and Recovery during Resistance Exercise in Healthy Male Adults
- Registration Number
- CTRI/2014/02/004422
- Lead Sponsor
- Shri Kartikeya Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
1.Adult males between 18 â?? 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
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 (â??regular drinkersâ??)
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement from baseline in the muscular strength and endurance after 8 weeksTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method â?¢Improvement from baseline in the muscle damage during resistance exercise analyzed by measuring the serum creatinine kinase (CK) 24 hours after the exerciseTimepoint: 8 weeks;Change in the serum testosteroneTimepoint: 8 weeks;Improvement in the body composition from baseline using BIATimepoint: 8 weeks;Improvement in the Muscle size from baselineTimepoint: 8 weeks