| CTRI Number |
CTRI/2022/03/041047 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for Hypothyroidism |
|
Scientific Title of Study
|
Efficacy of Integrated Yoga as an Effective Non-invasive Therapy in the Management of Hypothyroidism in Adults –
A Tele-Yoga Program
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savithri Nilkantham |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Swami Vivekananda Rd
Kalluballu Post
Anekal Jigani
Karnataka 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
9916669576 |
| Fax |
|
| Email |
savithri.nilkantham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Swami Vivekananda Rd
Kalluballu Post
Jigani
Bangalore
KARNATAKA
560105
India |
| Phone |
9341854502 |
| Fax |
|
| Email |
dramits90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchitra Patil |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Swami Vivekananda Rd
Kalluballu Post
Jigani
Bangalore
KARNATAKA
560105
India |
| Phone |
8197185991 |
| Fax |
|
| Email |
suchitra@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Rd
Kalluballu Post
Anekal Jigani
Karnataka 560105 |
| 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 |
| Savithri Nilkantham |
Swami Vivekananda Yoga Anusandhana Samsthana |
Swami Vivekananda Rd
Kalluballu Post
Anekal Jigani
Yoga and Life Sciences Division
Bangalore
KARNATAKA |
9916669576
savithri.nilkantham@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Waitlist Group |
3 Months Duration |
| Intervention |
Yoga Intervention |
3 Months Duration |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Patients with confirmed clinical diagnosis of Hypothyroidism.
-Patients consuming medication for hypothyroidism (Thyroxin / Eltroxin)
-People having not practiced yoga in the last 3 months
-People having access to Internet
-People having a smartphone, tablet, laptop or television
|
|
| ExclusionCriteria |
| Details |
- Thyroid Malignancy
- People with other auto-immune disorders
- People with severe psychiatric disorder
- Pregnant women
- People having undergone recent surgery in the last 6 months.
- Subjects with visual and hearing disabilities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To understand the effect of validated Yoga Module on primary variable of SF-36 (Health related quality of life scale).
|
Pre-day 0
Interim - day 90
Post - day 180 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To understand the effect of validated Yoga Module on the secondary variables of thyroid profile {T3, T4, TSH}, BMI, BP, questionaaire include -Fatigue Assessment Scale, Perceived Stree Scale, and Gita Inventory of personality. |
Pre - day 0
Interim - day 80
Post - day 120 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Scientific yoga module for hypothyroidism: A study protocol for tele-yoga RCT
2. Therapies to treat depression in hypothyroid patients
3. Development, validation, and feasibility of a tele-yoga module for patients with hypothyroidism
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thyroid gland, an endocrine gland secretes essential hormones, which influences various other functions of the mind-body system. Hypothyroidism occurs due to an underactive gland function whereby the secretion of thyroid hormones lack, causing disturbances in the functioning of the system. It has varied symptoms viz., fatigue, weight gain, intolerance to cold, skin conditions, depression, cognitive impairment and so on which may impact the quality of life negatively. Yoga is being increasingly used in experimental and clinical studies as they demonstrate positive effect in preventing and managing variety of endocrinal diseases without any side effect by re-establishing balance in the mind-body system using neuro-endocrine pathway. The objective of the study is to conduct a randomized control trial through Tele-yoga mode by administering the Validated Yoga Module on the hypothyroid subjects and to understand the effect of yoga intervention on bio-chemical variables and the overall quality of life of hypothyroid patients. |