| CTRI Number |
CTRI/2024/03/064807 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga practice in hypothyroidism patients
|
|
Scientific Title of Study
|
A study of the effect of yoga exercise in hyothyroidism patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheelendra kushwah |
| Designation |
Research Scholar |
| Affiliation |
Faculty of Ayurveda, IMS, BHU, Varanasi |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8864819138 |
| Fax |
|
| Email |
sheelendrakushah39@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Ayurveda, IMS, BHU, Varanasi |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Professore |
| Affiliation |
Institute of Medical Sciences Bhu |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, IMS, BHU, Varanasi
Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital, Faculty of Ayurveda, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi |
| Address |
IMS BHU, Varanasi-221005, UP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sheelendra Kushwah |
Department of Kayachikitsa, Faculty of Ayurveda, IMS, BHU, Varanasi-221005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meera Antiwal |
Sir Sunderlal Hospital, Varanasi |
Institute of Medical Science, Faculty of Ayurveda, Department of Kayachikitsa, OPD No. 21,22 Varanasi
Varanasi
UTTAR PRADESH |
9451586325
antiwalmeera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Science, Banaras Hindu University, Varanasi, India -221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E032||Hypothyroidism due to medicamentsand other exogenous substances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
yoga practice |
Yoga practice is popular as a successful and effective medical method. Through which complete mental health can be achieved, it makes the body healthy, strong and healthy, because it provides strength to fight diseases. At present, yoga practice is being used in the field of health not only in India but also abroad. The World Organization believes that yoga practice is a well-organized and scientific lifestyle, by adopting which many types of life-threatening diseases can be avoided. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Symptoms and criteria described for
hypothyroidism Selection will be done on the level of triiodothyronine, thyroxine, thyroid stimulating hormone,
2.4.5µIU ml to 30µIU ml of Thyroid Stimulating Hormone Level up to and of the drug, depending on body weight 1.6 µg kg, patients will be selected to use
3.Selected patients ranging in age from 20 to 65 years
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from pituitary hypothalamic disease or other non-thyroidal disease will not be selected.
2.Patients who are suffering from serious illness like cancer, paralysis or are incapable of speaking, mentally retarded etc. will not be selected.
3.Pregnant women, lactating women, etc. will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Triiodothyronine
2.Thyroxine
3.Thyroid stimulating hormone |
3 month with 1 follow-ups of every month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Weight
2.Body mass index
3.Systolic blood pressure
4.Diastolic blood pressure |
3 month with 1 follow-ups of every month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to evaluate the effect of yoga exercises on hypothyroidism patients. There are 120 samples in the study. Patients diagnosed with hypothyroidism who meet the inclusion criteria will be randomly allocated into two groups. The duration of study will be 3 months. Assessments will be conducted at the beginning of the study to determine baseline data. Hypothyroidism will be measured through a blood test. |