CTRI Number |
CTRI/2021/12/038864 [Registered on: 23/12/2021] Trial Registered Prospectively |
Last Modified On: |
22/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative study of structural and functional changes in the thyroid gland with introduction of Integrated yoga module in female hypothyroid patients |
Scientific Title of Study
|
Comparative evaluation of structural and functional changes in thyroid gland after implementation of integrated yoga module (IYM) as adjunct therapy versus conventional levothyroxine therapy in hypothyroid females. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Madhulika D Tiwari |
Designation |
Associate Professor |
Affiliation |
Datta Meghe Institute of Medical Sciences, Swangi, wardha |
Address |
Department of Rachana Sharir Datta Meghe Ayurvedic Medical College Hospital Research Centre Wanadondri Nagpur Department of Rachana Sharir Datta Meghe Ayurvedic Medical College Hospital & Research Centre Wanadondri Nagpur Nagpur MAHARASHTRA 441110 India |
Phone |
9158350066 |
Fax |
|
Email |
tiwari.madhulika8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pradnya Dandekar |
Designation |
Professor and Head |
Affiliation |
Datta Meghe Institute of Medical Sciences, Swangi, wardha |
Address |
Department of Kriya Sharir College building
Mahatma Gandhi Ayurved College Hospital and Research Center
Salod (H) Wardha Department of Kriya Sharir College building
Wardha Department of Kriya Sharir College building
Mahatma Gandhi Ayurved College Hospital and Research Center
Salod (H) Wardha Department of Kriya Sharir College building
Wardha Wardha MAHARASHTRA 442001 India |
Phone |
8999449334 |
Fax |
|
Email |
drpddandekar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Madhulika D Tiwari |
Designation |
Associate Professor |
Affiliation |
Datta Meghe Institute of Medical Sciences, Swangi, wardha |
Address |
Department of Rachana Sharir Datta Meghe Ayurvedic Medical College Hospital and Research Centre Wanadongri Nagpur Department of Rachana Sharir Datta Meghe Ayurvedic Medical College Hospital and Research Centre Wanadongri Nagpur Nagpur MAHARASHTRA 441110 India |
Phone |
9158350066 |
Fax |
|
Email |
tiwari.madhulika8@gmail.com |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Ayurvrda College hospital and research Centre Salod Wardha |
|
Primary Sponsor
|
Name |
Mahatma Gandhi Ayurved College Hospital Research centre DMIMS |
Address |
Salod wardha Maharashtra |
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 Madhulika D Tiwari |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Wardha |
Salod Wardha Maharashtra Wardha MAHARASHTRA |
9158350066
tiwari.madhulika8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: Hypothyroid females, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Thyroxine, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 25(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: thyroxine, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 25(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Along with Integrated Yoga Module (therapy) |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1.k/c/o –hypothyroid disorder
2.TSH >5mlU/L
3.Absence of severe psychotic disorders
|
|
ExclusionCriteria |
Details |
1.Congenital hypothyroidism
2.Secondary hypothyroidism
3.Tertiary hypothyroidism
4.Hypothyroidism during pregnancy
5.Patients of Malignancy related to thyroid, larynx and pharynx
6.Patients above the age of 40years
7.Slip disc, recent surgery
8.Low back pain.
9.Patients suffering from systemic disorders HTN, BA,
10.Those patients who have been advised thyroidectomy.
11.Already practicing Yoga/exercise for thyroid.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
decrease in TSH level in comparison to the TSH level in First visit(zero day) |
decrease in TSH level from zero day to thirty sixty and ninty days |
|
Secondary Outcome
|
Outcome |
TimePoints |
changes in structure of thyroid gland |
3 months |
|
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
|
N/A |
Date of First Enrollment (India)
|
30/12/2021 |
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="2" Months="1" Days="15" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The aim of this study is to evaluate the effect of integrated yoga module as adjunct therapy on patients of hypothyroid disorder. The patients enrolled for the study will be distributed randomly in two groups Study Group and Control group. The study group will be made to follow Integrated yoga module along with prescribed medicine, whereas the Control group will just be observed with prescribed medicine. The structural and functional changes will be evaluated after intervention. Also the correlation between endocrine gland and vishuddha chakra will be discussed. |