Evaluation of the add on effect of Majoone Sarkhas with levothyroxine in primary hypothyroidism: a randomized standard control adjuvant clinical study.

Abstract

Objectives: Primary hypothyroidism is a prevalent endocrine disorder, typically treated with levothyroxine (LT). However, prolonged use of LT may result in complications and suboptimal outcomes for some patients. Majoone Sarkhas (MS), is a polyherbal formulation comprises four plants: Commiphora mukul, Operculina turpethum, Embelia tseriam-cottam, and Dryopteris filix-mas. It is traditionally used in Unani medicine for managing hypothyroidism associated conditions. The aim of this study was to assess the synergistic effect of Majoone Sarkhas in combination with LT for the treatment of primary hypothyroidism.

Methods: This randomized, single blind, standard clinical trial involved 100 subjects allocated into two groups: an adjuvant treatment group (n=50) and a standard control group (n=50). The adjuvant group received 10 g of MS twice daily in addition LT once daily, while the control group was treated with LT alone once daily. Both groups underwent treatment for 60 days. Changes in thyroid-stimulating hormone (TSH), free tri-iodothyronine (FT3), and free-thyroxine (FT4) levels from baseline to the 60th day were recorded and analyzed statistically to evaluate the outcomes.

Results: The study showed adjuvant group (MS + LT) had more reduction (4.99 vs. 3.93) in serum TSH level in comparison to control group (LT), which was statistically significant (p<0.001), it also showed increase in serum FT3 (2.88 ± 0.31 vs. 2.97 ± 0.44) and FT4 (1.06 ± 0.17 vs. 1.20 ± 0.27) levels, when compared with baseline values and after completion of trial.

Conclusions: The change in thyroid function profiles among adjuvant group, receiving MS with LT in primary hypothyroidism was both clinically and statistically significant. The safety parameters those were followed by serum level of ALT, AST, blood urea and serum creatinine were within the range, indicating the MS is safe medication to be used as an adjuvant therapy with LT (Clinical Trial Registration Code: CTRI/2018/02/011962).