Abstract
<p class="abstract"><strong>Background:</strong> A huge population in India is at high-risk of developing thyroid related disorders. Unhealthy lifestyle (lack of physical activity and consumption of junk food) is common among Indian population. Yoga is a form of physical activity and helps prevent many lifestyle disorders. The research question to be addressed by this randomised controlled trial (RCT) is whether yoga based intervention is effective in preventing overt hypothyroidism among sub clinical hypothyroid people in India as compared to untreated participants.</p><p class="abstract"><strong>Methods:</strong> This is a single-blinded, two-arm, parallel-group RCT. Eligible participants should be aged 21-59 years, suffering from sub clinical hypothyroidism (serum thyroid stimulating hormone i.e. TSH level 4.2 mIU/l &gt;TSH level &lt;10 mIU/l; T3 and T4 within normal range). At least 100 participants will be randomised either to the intervention group or the control group. Intermediate follow up at 3 month and final follow-up will be at six month post intervention. This study is designed to study the effect of yoga intervention on biochemical tests {thyroid function tests (fT3, fT4 and TSH)}, physical parameters (waist circumference, waist hip ratio, fat percentage and BMI) and psychological parameters {quality of life (QOL) as assessed by World Health Organization (WHO)-QOL, sleep quality (assessed by PSQI) and depression (assessed by BDI-II)} in sub-clinical hypothyroid patients.</p><p class="abstract"><strong>Conclusions: </strong>We are now conducting a RCT in Delhi, India to assess the efficacy of yoga in preventing progression of subclinical- hypothyroidism to overt hypothyroidism. If the yoga intervention used in this study is effective, it will be a low-cost feasible treatment for subclinical hypothyroidism in India.</p><p><strong>Trial registration:</strong> Trial registration number is CTRI/2020/03/024023.</p>
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