| CTRI Number |
CTRI/2019/12/022482 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
07/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on effect of yoga on autonomic nervous system in hypothyroid patients |
|
Scientific Title of Study
|
Effects of three month of yoga therapy on autonomic functions, oxidative stress ,Inflammatory markers in hypothyroid patients on thyroid supplement, A cross sectional, analytical, randomized open label study in a tertiary care centre ,in South India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravati Pal |
| Designation |
Professor and Head |
| Affiliation |
JIPMER |
| Address |
Deptartment of Physiology,
JIPMER Academic Centre,
Gorimedu,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360682406 |
| Fax |
|
| Email |
drpravatipal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravati Pal |
| Designation |
Professor and Head |
| Affiliation |
JIPMER |
| Address |
Deptartment of Physiology,
JIPMER Academic Centre,
Gorimedu,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360682406 |
| Fax |
|
| Email |
drpravatipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthiga J |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Deptartment of Physiology,
Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9566506523 |
| Fax |
|
| Email |
karthigajayabal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post graduate Medical Education and Research,
Dhanvantari nagar,
Puducherry,
Pincode-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post graduate Medical Education and Research |
| Address |
Jawaharlal Institute of Post graduate Medical Education and Research,
Dhanvantari nagar,
Puducherry,
Pincode-605006
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pravati Pal |
JIPMER , puducherry |
No. 8123,JIPMER academic center,JIPMER, Dhanvantari nagar,
Pondicherry
PONDICHERRY |
9360682406
drpravatipal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autonomic function test parameters and biochemical markers will be compared to hypothyroid patients taking thyroid supplements |
Autonomic function test parameters (HRV, BRS)and biochemical markers( oxidative stress and inflammatory markers) will be compared to hypothyroid patients undergoing three months of yoga therapy in addition to thyroid supplements. |
| Intervention |
Yoga therapy will be given as intervention. |
Three months of yoga therapy will be given as intervention .
Structured yoga therapy will be taught in Advanced Center of Yoga Therapy and Research (ACYTER) in JIPMER for three hours in a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Hypothyroid patients of both genders belonging to age group of 18 to 50 with TSH value below 10 units will be included in study |
|
| ExclusionCriteria |
| Details |
Diabetes Mellitus,
Hypertension,
Heart disease,
Autonomic Dysfunction
Those taking Chronic Drugs that can influence autonomic function,
Those doing Yoga Practice |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| expected difference in mean of total power of heart rate variablity is 3.4 |
Improvement in total power of heart rate variablity in hypothyroid patients undergoing yoga therapy at end of three month (12 weeks ) from baseline recording |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvises the thyroid profile,lipid profile, antioxidant level and lowers the oxidative stress and inflammatory markers like IL-6,TNF -Alpha in hypothyroid patients undergoing yoga therapy. |
Three months of yoga therapy reduces the inflammatory markers and oxidative stress. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2019 |
| Date of Study Completion (India) |
15/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/09/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an interventional study which studies effect of yoga therapy on hypothyroid patients in addition to thyroid supplementation. From rural and urban population from Puducherry and nearby districts of Tamilnadu ,the participants attending Endocrinology OPD in JIPMER will be screened and a detailed history will be obtained. After meeting the inclusion and exclusion criteria, the participants will be divided into two groups ( Intervention group and Control group) based on computer generated sequence .5 ml of fasting blood sample will be collected for biochemical analysis, following which breakfast will be provided to them. After breakfast , heart rate variability and baroreceptor sensitivity will be recorded.Then yoga therapy will be given in ACYTER (Advanced Center of Yoga Therapy and Educational Research) as per the protocol, three times in a week for Intervention group. The participants in the Yoga group are advised to practise Yoga for a period of three months. After three months ,the primary outcome heart rate variability and baroreceptor sensitivity and secondary outcomes like TNF- alpha, IL-6 ,total oxidant and antioxidant level will be taken in both groups and will be compared. |