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CTRI Number  CTRI/2022/01/039255 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 18/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study held to see the effect of yoga module on hypothyroidism. 
Scientific Title of Study   A randomized clinical controlled trial to study the add on effect of yoga module on hypothyroidism. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshat sirdhyal 
Designation  MD Scholar swasthavritta 
Affiliation  Dr D Y Patil College of Ayurveda And Research Centre  
Address  Department of swasthavritta Opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra
Department of Swasthavritta Opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  8219678145  
Fax  411018  
Email  drakshatsirdhyal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyotsna Vitthalrao Yadav 
Designation  Associate Professor Swasthavritta 
Affiliation  Dr D Y Patil College of Ayurveda And Research Centre 
Address  Department of Swasthavritta Opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri pune 411018 Maharashtra
Department of swasthavritta opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri pune 411018 Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  9518748341  
Fax    
Email  drjyotsnahande1988@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akshat sirdhyal 
Designation  MD Scholar swasthavritta 
Affiliation  Dr D Y Patil College of Ayurveda And Research Centre  
Address  Department of Swasthavritta Opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra
Department of Swasthavritta Opd no. 7 Ground floor Dr D Y Patil College of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  8219678145  
Fax    
Email  drakshatsirdhyal@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra 
 
Primary Sponsor  
Name  Akshat Sirdhyal 
Address  Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra 
Type of Sponsor  Private medical college 
 
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 
Akshat Sirdhyal  Dr D Y Patil College Of Ayurveda And Research Centre   Opd no. 7 Ground floor Swasthavritta Department Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA 		 8219678145
411018
drakshatsirdhyal@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:E039||Hypothyroidism, unspecified. Ayurveda Condition: Hypothyriodism, (2) ICD-10 Condition: E039||Hypothyroidism, unspecified, (3) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:Yoga Module 1. Suksham vyayam ( Warm up) (5 mins) 2. Jalandhar Bandha (3 mins) (3 rounds) 3. Matsyasana (3 mins) (3 rounds) 4.Sinhasana (3 mins) (3 rounds) 5. Ushtrasana (3 mins) (3 rounds) 6. Ujjayi Pranayama (3 mins) (3 rounds) Time: 7 am to 8 am daily Duration: 28 days, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator Arm (Non Ayurveda)-tab. thyroxinThe tablet thyroxin 75mg OD
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Pre diagnosed hypothyroidism individuals of either sex of age group between 18-55 years.

Patients with hypothyroidism who are interested in involving themselves in yogic practices

Individual who give consent 
 
ExclusionCriteria 
Details  Nervous system, respiratory ailments and hypertension

Cardiovascular diseases and locomotors disabilities

Recent abdominal and spinal surgeries

Pregnant and lactating women

Patients who are contraindicated for that aasana 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Yoga module is effective in the management of hypothyroidism.

2. There is significant effect of Yoga Module on TSH level
 		 28 days study with 1 follow up (0,28 day) 
 
Secondary Outcome  
Outcome  TimePoints 
There is significant effect of Yoga Module on BMI, BMR and Fat Percentage  28 days study with 1 follow up (0,28 day) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/03/2022 
Date of Study Completion (India) 15/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 study is to see the effectiveness of yoga module in the management of hypothyroidism and to evaluate the changes in BMR, BMI. The study will be conducted with 60 patients showing sings and symptoms of hypothyroidism. They will do the given yoga module once in a day for 28 days and the follow up will be done on  28th day and conclusion will be drawn on the bases of proper statistical methods. 
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