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Study of Ashwagandha (Withania somnifera) on Muscle Strength, Endurance and Recovery during Resistance Exercise in Healthy Male Adults

Phase 4
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Improvement from baseline in the muscular strength and endurance after 8 weeksTimepoint: 8 weeks
Secondary Outcome Measures
NameTimeMethod
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
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