| CTRI Number |
CTRI/2021/09/036650 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
11/09/2021 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of integral yoga intervention including selected yogic practices on underactive thyroid of adult females. |
|
Scientific Title of Study
|
Yogic management of hypothyroidism in females |
| Trial Acronym |
YMHF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rudra Bhandari |
| Designation |
Assistant professor |
| Affiliation |
University of Patanjali |
| Address |
Maharshi Dayananda Gram, Delhi Haridwar National Highway, Near Bahadrabad, Patanjali Yogpeeth Phase 1, Haridwar
Department of Yogic Science, University of Patanjali, Haridwar, Uttrakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
uop.rudra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pintu kumar Mahto |
| Designation |
Ph.D.scholar |
| Affiliation |
University of Patajali |
| Address |
Department of Yogic Science,University of Patanjali, Haridwar
Room no- 416,Department of yogic science, University of Patanjali, Patanjali Yogpeeth 1,Delhi National Highway, Near Bahadrabad, Haridwar,, Uttrakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8755565273 |
| Fax |
|
| Email |
pintuk269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pintu kumar Mahto |
| Designation |
Ph.D.scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yogic Science,University of Patanjali, Haridwar
Room No-416, Patanjali
Ayurved College, Patanjali Yog peeth, Haridwar , Uttrakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8755565273 |
| Fax |
|
| Email |
pintuk269@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Patanjali Yog Peeth, Roorkee-Haridwar Road, Haridwar, Uttarakhand 249405 |
| 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 Rudra Bhandari |
Patanjali Ayurveda Hospital |
Room no-416,Patanjali Ayurveda College, Patanjali Yogpeeth 1,,Haridwar
Hardwar
UTTARANCHAL |
9634510540
uop.rudra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, University of Patanjali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (2) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Wait listed(31) |
No specific intervention upto 3 months for Wait listed group(31) |
| Intervention |
Yogic Practices |
The present Double arm pre-post design would be conducted in 62 sixty-two women participants. Thyroid medication would be kept constant during the study period in both the groups (EG, WLG). Out of which 31 in EG would be receiving intervention comprising asanas, pranayama, and relaxation techniques for 60 min daily (5 days a week). And also included Yoga practises : Kunjal, Jal / sutra neti, Paschimottanasana , Halasana ,Matasyasana, Bhujangasana, Dhanurasana , Setubandhasana,Uni nostril, and Alternate Nostril Breathing, Crown Breathing, Throat Breathing,Ujjayi , Bhramari, Jalandhar, Mulbandha , Uddiyan Bandha, Vipreetkarni mudra, Savita Guided Meditation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Females
2. Age Between 18-55 Years
3. Pre-Diagnosed Hypothyroidism Patient
4. Patient with hypothyroidism who are interested in involving themselves in yogic practice
• Primary, secondary, tertiary hypothyroidism patients.
|
|
| ExclusionCriteria |
| Details |
1. Males
2. Nervous system or respiratory ailments, hypertension and diabetes mellitus
3. Cardiovascular disease, renal complications, liver disorders and locomotors disabilities
4 Glaucoma, hernia, or ulcers of the stomach or intestine
5. Recent abdominal or spinal surgery
6. Obese female with pregnancy or Lactation and children
7. Any type of Addiction like smoking, alcoholism, tobacco chewing, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Yoga may be the one of the cost-effective options to prevent and manage hypothyroidism and its comorbidities.
â— To highlight the effect of yoga practices for management of underactive hypothyroidism.
|
Baseline measurement followed by post measurement after three months integral yoga protocol intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TSH,T3,T4, BMI,Lipid profiles, Depression, The Beck Depression Inventory, Self-Efficacy Measure for Sleep Apnea |
Baseline and Post Intervention Measurement of Secondary Outcome Variables will be completed in 12 weeks and one week respectively |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
07/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be published in PubMed in dexed journal/s |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Various studies on thyroid reveal that approximately 42 million people in India suffered from thyroid disease(Taylor et al., 2018). The population-based study on the pervasiveness of hypothyroidism was 3.9% among 971 adults (Trifu et al., 2020) and the prevalence in women is higher (11.4%) as compared to men (6.2%) (Maske & Barnwal, 2016). Objectives To assess the effect of selected yogic practices on T3and T4 of females with hypothyroidism. To assess the effect of selected yogic practices on TSH of females with hypothyroidism. To assess the effect of selected yogic practices on comorbidities induced by hypothyroidism: depression, sleep apnea, BMI and lipid profile
Study Design Two armed RCT with 31 clinically significant Hypothyroidism patient control group. Hypothyroidism patient aged from 18-55 years and Patient with hypothyroidism who are interested in involving themselves in yogic practice which include, Primary, secondary, tertiary hypothyroidism patients. Those with severe prior health complications and infidelity to yoga will be excluded.
Measures The Beck Depression Inventory(BDI), Self-Efficacy Measure for Sleep Apnea SEMSA, Serum thyroxine(T4), Serum Triiodothyronine (T3), Serum thyrotropin(TSH)
|