Yoga for Controlling Subclinical-Hypothyroidism

Phase 2

Conditions: Health Condition 1: E038- Other specified hypothyroidism

Registration Number: CTRI/2020/03/024023

Lead Sponsor: Department of Science and Technology Govternment of India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients of Subclinical Hypothyroidism

1 T3 level normal range ( 2.0 - 4.0 pg/ml)

2 T4 level normal range (0.8â?? 1.8 ng/dl)

3 4.2 mIU/L > TSH level <10 mIU/L Normal range (0.5 - 4.20 mIU/L)

4. Subclinical hypothyroidism patients with or without Thyroid Peroxidase (TPO) antibody test positive.

Exclusion Criteria

1. Patients suffering from Obesity grade III

2.TSH level >10 mIU/L

3.Diabetes Mellitus Patients who are on Insulin and Poorly controlled Type â??II diabetes mellitus patients where HbA1c > 10%

4.Patients who have a past history of severe cardiac dysfunction (a trial fibrillation, Heart failure, myocardial infarction, uncontrolled hypertension, or stroke).

5.Patients with concurrent serious hepatic disorders defined as AST and/or ALT > 3 times of the upper normal limit.

6.Patients with concurrent serious renal disorders defined as serum creatinine > 1.5mg/dl.

7.Patients with concurrent serious pulmonary dysfunction.

8.Patient with cerebrovascular event during the last 12 months.

9.Women who are pregnant or lactating or planning pregnancy in near future.

10.Patient with any type of tumour or malignancy or any history of malignancy.

11.Drugs and Alcohol dependents.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out the effect of Yoga intervention on Thyroid function tests (fT3, fT4 and TSH), serum Anti-TPO antibody levels. <br/ ><br> <br/ ><br>2.To study the effect of Yoga modalities on Quality of life as assessed by WHO-QOL, Sleep quality (assessed by PSQI) and depression (assessed by BDI-II). <br/ ><br> <br/ ><br>3. To assess effects of Yoga intervention on Central obesity in hypothyroidism by measuring waist circumference, waist hip ratio, fat percentage and BMI levels. <br/ ><br>Timepoint: Baseline, 3 month, 6 month

Secondary Outcome Measures

Name	Time	Method
-To study the effect of Yoga modalities on Quality of life as assessed by WHO-QOL, Sleep quality (assessed by PSQI) and depression (assessed by BDI-II). <br/ ><br> <br/ ><br>-To assess effects of Yoga intervention on Central obesity in hypothyroidism by measuring waist circumference, waist hip ratio, fat percentage and BMI levels. <br/ ><br>Timepoint: Baseline, 3 month, 6 month