| CTRI Number |
CTRI/2020/08/026970 [Registered on: 04/08/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga therapy and Brisk walking on hypothyroidism |
|
Scientific Title of Study
|
A Randomized clinical study to compare effect of yoga therapy and brisk walking on serum TSH in subclinical hypothyroidism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Kumar |
| Designation |
M.D. Scholar, Department of Swasthvritta and Yoga |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9929378950 |
| Fax |
|
| Email |
drsureshkumarnia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Assistant Professor,Department of Swasthvritta and Yoga |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8278610350 |
| Fax |
|
| Email |
drravikumar786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAjay Kumar Sahu |
| Designation |
Assistant Professor,Department of Kaya Chikitsa |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kaya Chikitsa, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Near Jorawar Singh Gate Amer Road Jaipur- 332002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Ravi Kumar |
National Institute of Ayurveda |
Room no-21 yoga unit in front IPD madhava vilas near jorawar singh gate
Amer road jaipur
Jaipur
RAJASTHAN |
8278610350
drravikumar786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E018||Other iodine-deficiency related thyroid disorders and allied conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga and Bricks walking |
90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptomatic or asymptomatic subjects 18- 60 years of either sex.
2. Serum FT3 -Normal range
3. Serum FT4 - Normal range
4. Serum TSH - between 4.12 and 9.9 mU/L as an outpatient (both values included)
5. Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Serum TSH - <4.12 and >9.9 mU/L as an outpatient
2. Serum FT4 - outside normal limit
3. Serum FT3 – outside normal limit
4. Thyroidictomy
5. Obesity BMI > 35
6. Radiation therapy to neck area
7. Radioactive iodine treatment
8. Pregnant ladies
9. Diagnosed patients suffering with any other chronic systemic disease e.g. cardiac problem, DM, hypertension. T.B. etc.
10. Secondary hypothyroidism, tertiary hypothyroidism
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there is any effect of yoga karma in serum TSH in sub clinical hypothyroidism |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is any effect of brisk walking on serum TSH in sub clinical hypothyrodism with the help of subjective and objective parameters. |
3 month |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/08/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
a Randomized Clinical study to compare effect of yoga therapy and brisk walking on serum TSH in sub clinical hypothyrodism for 90 days.
Null Hypothesis - There is no difference in serum TSH level after Yoga therapy and Brisk walking.
Alternate Hyposthesis There is a difference in serum TSH level after Yoga therapy and Brisk walking. |