A clinical study on subclinical hypothyroidism and its management with an extract of Jawarish e Bisbasa formulation: A randomized double-blind placebo-controlled clinical trial

Abstract

Subclinical Hypothyroidism is defined as a condition in which the serum thyroid stimulating hormone level is above the normal reference range, but serum thyroxine T4 and tri iodo thyronine T3 levels (free and total) are within the normal range. The majority of patients with Subclinical Hypothyroidism show no clinical features of thyroid dysfunction. In a large screening population, the overall percentage of SCH ranges from 5 to 10%. In this clinical study, a polyherbal Unani formulation Jawarish e Bisbasa consisting of bisbasa (Myristica fragrans), zanjabeel (Zingiber officinalis), asarun (Valeriana wallichii), taj qalmi (Cinnamomum cassia), darchini (Cinnamomum zeylanicum), filfil siyah (Piper nigrum), qaranfal (Szygium aromaticum), filfil daraz (Piper longum), heel khurd (Elettaria cardamomum), heel kalan (Amomum subulatum) in the form of extract, was tested and found highly significant in terms of efficacy as well as safety. The test formulation (hydroalcoholic extract) was well tolerated and no adverse/ side effects were observed during the entire period of protocol therapy in any patient in the test group. The dosing load was also reduced to one-tenth of its semisolid form.