CTRI/2019/07/019976CompletedPhase 3
Effect of crude Ashwagandha powder (Withania somnifera) on performance level in Aerobic athletes(18-30 years)
Shivani Sharma D Preethi Jyothsna1 site in 1 country50 target enrollmentStarted: July 15, 2019Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Assessment of VO2 max
Study Overview
Brief Summary
This study is a non-randomised,active group trial comparing the performance levels in aerobic athletes by supplementing 2gm Ashwagandha powder through a bread roll daily for 2months in 25 subjects while the remaining 25 subjects will be the control group. The study will be conducted at Manipal, India.The primary outcome measures will be assessment of VO2 max values on day zero, 4th and 8th week.
The secondary outcome measure will be assessment of VO2 max values post supplementation, i.e. a week after the 8th week.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy Endurance athletes.
- •People who perform exercise for 3 to 4 days a week minimum 1 hour.
Exclusion Criteria
- •People who smoke.
- •People taking anabolic steroids.
- •People with a present co-morbid medical condition like Hypertension, Diabetes, and Hypotension, Cardiovascular disease or any other heart related issues, Asthma, respiratory problems, thyroid disorders and gastro intestinal disorders.
- •People with any food allergies.
Outcomes
Primary Outcomes
Assessment of VO2 max
Time Frame: day 0, 4th week, 8th week
Secondary Outcomes
- Assessment of VO2 max(Post supplementation i.e.a week after the 8th week)
Investigators
Study Sites (1)
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