Comparative Effectiveness of Varunadi Ghan Vati and Kanchnar Guggulu in Management of Subclinical Hypothyroidism- Study Protocol for a Randomized Controlled Trial

Abstract

Abstract: Background: Hypothyroidism is an emerging disease nowadays. India has a high prevalence of Hypothyroidism, which is about 10%. Hormone replacement therapy is advised in the treatment of hypothyroidism. However, in subclinical hypothyroidism, no treatment is advised. Ayurveda describes a number of treatment modalities for the treatment of disease on the basis of their dosha-dushya. The aim of this study is to evaluate the effectiveness of Varunadi Ghan Vati in comparison with Kanchnar Guggulu in the management of subclinical hypothyroidism. Methods and Design: This study will be a prospective, single-centered, randomized controlled trial. A total of 60 patients of age between 19 and 60 years, diagnosed with subclinical hypothyroidism, and presented with cardinal features of the disease will be randomized into two groups. In Group A, patients will be given Varunadi Ghan Vati and in Group B patients will be given Kanchnar Guggulu. Pathya-Apathya regarding the disease will be guided to both groups. Both groups will receive treatment for 45 days. Outcomes will be evaluated on the 15th, 30th and 45th days (during treatment) and 75 th day(post-treatment). The primary outcome will be evaluated on the basis of cardinal symptoms of subclinical hypothyroidism. Improvement in laboratory investigations will be evaluated for secondary outcomes. Conclusion: This trial is the first to compare the effectiveness of Varunadi Ghan Vati with Kanchnar Guggulu in the management of subclinical hypothyroidism. Varunadi Ghan Vati is expected to improve the symptoms of subclinical hypothyroidism, thus proving to be effective in the management of patients with subclinical hypothyroidism. Trial registration: CTRI/2023/07/055295