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CTRI Number  CTRI/2020/12/029706 [Registered on: 10/12/2020] Trial Registered Prospectively
Last Modified On: 07/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Yoga and Medical Nutrition Therapy on pregnancy outcomes among women with hypothyroidism 
Scientific Title of Study   “A randomized controlled trial to assess the effectiveness of Yoga and Medical Nutrition Therapy on pregnancy outcomes among women with hypothyroidism at tertiary care setting in Udupi District, Karnataka”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Anusuya V Prabhu 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Department of Child Health Nursing. Manipal College of Nursing Manipal. MAHE, Manipal
Department of Child Health Nursing.Manipal College of Nursing Manipal. MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9901731734  
Fax    
Email  anusuya.prabhu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyamala G 
Designation  Professor 
Affiliation  KMC Hospital 
Address  Department of OBG Kasturba hospital MAHE Manipal
Department of OBG Kasturba hospital MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9844551037  
Fax    
Email  shyamala.g@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mrs Sushmitha Karkada 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Department of OBG Nursing.Manipal College of Nursing Manipal. MAHE, Manipal
Department of OBG Nursing. Manipal College of Nursing Manipal. MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9964144224  
Fax    
Email  sushmitha.karkada@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba hospital MAHE, Manipal 
 
Primary Sponsor  
Name  Manipal College of Nursing Manipal 
Address  Manipal College of Nursing Manipal MAHE Madhav nagar Manipal576104 Udupi Karnataka India 
Type of Sponsor  Other [Educational/Research Institution] 
 
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 
Mrs Anusuya V Prabhu  Kasturba Hospital Manipal  OBG OPD Kasturba Hospital Manipal Room number 10. MAHE Manipal
Udupi
KARNATAKA 		 9901731734
09738863278
anusuya.prabhu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital Institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O098||Supervision of other high risk pregnancies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Yoga and Medical nutrition therapy  Yoga therapy will be provided by the yoga therapist on monthly intervals starting from 16th weeks of gestation (4th month). The study subjects will be directed to practice the yoga therapy at home twice a day for 30 to 40 minutes. Which includes simhasana and pranayamas like anuloma viloma, suryabhedana, bhramari, ujjayee, bhahya khumbaka and soham meditation. Medical nutrition therapy includes holistic dietary advice and requesting the participants to avoid goitrogenic food items 
Intervention  Yoga and Medical Nutrition Therapy on pregnancy outcomes among women with hypothyroidism  Women in the intervention group will receive advice regarding yoga therapy. Yoga therapy will be provided by the yoga therapist on monthly intervals starting from 16th weeks of gestation (4th month). The study subjects will be directed to practice the yoga therapy at home twice a day for 30 to 40 minutes and maintain a dairy (provided by the investigator) for the same. At each visit, the investigator will check for compliance by using a brief questionnaire. Besides, the investigator will check for compliance through random phone calls. Medical Nutrition Therapy: In this study, Medical Nutrition Therapy, refers to the dietary modification that may help in improving the thyroid function. (Annexure 2). The intervention advice will start from 16 weeks of pregnancy, when subjects will be given a booklet containing the advice. At the time of enrolment at 12 weeks, women randomized for intervention will be provided with a chart for 24 hr diet recall, which they will be asked to do for 3 days before their next visit (16 weeks). One of the days for the dietary recall will be a non-working day. From 16 weeks women will have monthly dietary recall till delivery. Besides, the investigator will assess the dietary intake every month through a food frequency questionnaire.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Inclusion criteria:
Phase I:
• Singleton pregnant women who have delivered at the facility and had their booking in first trimester at the facility itself and had TSH estimation as a part of routine investigation will be considered (Those with known thyroid dysfunction also will be included).
Phase II:
• pregnant women with singleton pregnancy diagnosed with hypothyroidism (at their first antenatal visit during the first trimester) and intending to deliver at the same facility (Those with known thyroid dysfunction also will be included).
 
 
ExclusionCriteria 
Details  Exclusion criteria:
Phase II:
• Pregnant women with:
- Multiple pregnancies
- Overt Diabetes Mellitus
- Chronic hypertension
- Cardiac disorders
- Renal disorder
- Hepatic disorders
- Epilepsy on treatment
- Connective tissue disorders

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
maternal fetal and neonatal  monthly outcome evaluation till delivery 
 
Secondary Outcome  
Outcome  TimePoints 
The reference level of Thyroid Stimulating Hormone (TSH) during the first trimester among pregnant women.  First trimester  
 
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   Phase 2 
Date of First Enrollment (India)   17/12/2020 
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="6"
Months="9"
Days="9" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In this study, yoga refers to the selected pranayama, asana and meditation. These will be taught by the yoga therapist from Kasturba hospital Manipal during their antenatal visits from the 16th week of gestation till the 36th week. One session will be held individually per month. If they feel discomfort sitting on the floor, chairs will be provided. Pregnant mothers will have to practice these twice daily till their delivery.

Pranayama includes Anuloma viloma, Suryabhedana, Ujjayee, Bahya Kumbhaka, Bhramari pranayama for 25 minutes and Meditation (Dhyana) includes Soham meditation which is for 10 minutes. Asana for 10 minutes. Preparation and practice is 10 + 45 = 55 minutes. The participants will have to practice these twice a day (morning and evening) and maintain a note regarding the same in the diary book. A diary book will be provided by the investigator at the completion of their first session.

Dietary advice: Pregnant women will be requested to give 24-hour dietary recall for one week (alternate days). Certain vegetables such as legumes, cabbage, cauliflower, broccoli, turnip, forms of root cassava are goitrogens. Soy or soy enriched foods can aggravate thyroid problems reducing T4 absorption and interfering with thyroid hormone action. Dietary advice will be given by the investigator regarding minimizing the consumption of the above-mentioned foods.

 
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