Study on the effect of an Ayurvedic energy drink on the fitness and intelligence of healthy young adults.
Phase 2
- Registration Number
- CTRI/2023/05/052862
- Lead Sponsor
- Department of Swasthavritta & Yoga, Tilak Ayurved Mahavidyalaya and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Healthy volunteers having Fatigue Assessment Scale scores between 10 to 50.
2. Body Mass Index between 18.5 to 29.5
3. Healthy young adults as determined by screening assessments and Researcher judgment.
Exclusion Criteria
1. Healthy volunteers having Mrudu Koshtha.
2. Volunteers with known case of cardiovascular diseases and or diabetes mellitus.
3. Users of psychoactive substances e.g. caffeine, alcohol, nicotine and certain pain medicines, etc.
4. Healthy volunteers having nutritional supplementation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the performance of Fitness and Cognition of healthy young adults without developing any adverse drug reactions.Timepoint: For self-control 70 volunteers. <br/ ><br>Group A from day 1 to 15 for observations only. <br/ ><br>The same volunteers - Group B from day 15 to 30 for actual drug trial. <br/ ><br>The assessments For fitness - VO2 Max, HR, BP, Hand Grip Strength test and for Cognition - Concentration Grid test, and Digit Span test will be done on pre-test (day 1), follow up 1 (day 15), after Panak assessment (day 15) and follow up 2 post-test assessment (day 30). <br/ ><br>The outcomes will be assessed on day 15 and day 30.
- Secondary Outcome Measures
Name Time Method Decrease in the Fatigue Assessment Scale score against the initial score and preventing fatigue in healthy young adults.Timepoint: Day 1 and day 30. <br/ ><br>The Fatigue Assessment Scale score will be calculated on day 1st (pre-test i.e without Shramhar Kashyavarga Panak) and day 30th (post-test i.e with Shramhar Kashyavarga Panak). <br/ ><br>Total duration of the study will be 24 months.