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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: Hypothyroid females,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther 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:
2Intervention ArmDrugOther 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. 
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