A double-blind, randomized, placebo-controlled trial evaluating add-on individualized homoeopathic medicines to standard care in improving signs and symptoms of hypothyroidism in children and adults

Hypothyroidism is one of the most common endocrinal disorders under the medical concern, and its incidence is gradually increasing day-by-day. Currently, the standard treatment is thyroid replacement therapy with Levothyroxine; however, a substantial proportion of patients who reach biochemical treatment targets have persistent complaints. There is consensus that treatment should be indicated in a patient in a more comprehensive way, for long as it takes for physical and mental effects to subside. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in hypothyroidism has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homeopathic medicines in the treatment of hypothyroidism in children and adults. A double-blind, randomized, placebo-controlled trial will be taken up on 64 children and adults with hypothyroidism at D. N. De Homoeopathic Medical College & Hospital. Participants will be randomized to receive either homeopathic medicines plus standard care, or identical-looking placebo pills plus standard care. Primary outcome measure is Zulewski clinical score, to be measured at baseline, every month, up to 3 months. Secondary outcome measures are serum TSH, T3 and T4, to be measured at baseline and after 3 months; and Thypro questionnaire, to be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.