| CTRI Number |
CTRI/2019/07/019976 [Registered on: 01/07/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A practical trial to study the effect of natural Ashwagandha powder on Cardio respiratory athletes, aged between 18-30 years. |
|
Scientific Title of Study
|
Effect of crude Ashwagandha powder (Withania somnifera) on performance level in Aerobic athletes(18-30 years) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Sharma |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School Of Hotel Administration MAHE |
| Address |
Welcomgroup Graduate School Of Hotel Administration
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8319617676 |
| Fax |
|
| Email |
shivanisharma2259@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi Acharya |
| Designation |
Assistant Professor-senior scale |
| Affiliation |
Welcomgroup Graduate School Of Hotel Administration MAHE |
| Address |
Welcomgroup Graduate School Of Hotel Administration
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535071393 |
| Fax |
|
| Email |
swathi.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Swathi Acharya |
| Designation |
Assistant Professor-senior scale |
| Affiliation |
Welcomgroup Graduate School Of Hotel Administration MAHE |
| Address |
Welcomgroup Graduate School Of Hotel Administration
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535071393 |
| Fax |
|
| Email |
swathi.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Shivani Sharma
Dept. of Dietetics and Nutrition
Welcomgroup Graduate School of Hotel Administration,
MAHE,
Manipal
576104
|
|
|
Primary Sponsor
|
| Name |
Shivani Sharma D Preethi Jyothsna |
| Address |
Welcomgroup Graduate School of Hotel Administration
MAHE
Manipal |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shivani Sharma |
Manipal Academy of Higher Education |
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8319617676
shivanisharma2259@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Healthy Endurance athletes.
2. People who perform exercise for 3 to 4 days a week minimum 1 hour
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Supplementation of Ashwagandha Bread rolls |
Crude Ashwagandha powder 2 gms in a bread roll for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Endurance athletes.
2. People who perform exercise for 3 to 4 days a week minimum 1 hour |
|
| ExclusionCriteria |
| Details |
1. People who smoke.
2. People taking anabolic steroids.
3. 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.
4. Age below 18 and above 30 years.
5. People with any food allergies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of VO2 max |
day 0, 4th week, 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of VO2 max |
Post supplementation i.e.a week after the 8th week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
31/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |