Effect of combination of Curcuma longa with Emblica officinalis in females with polycystic ovarian syndrome: An open-label, randomized active-controlled, exploratory clinical study

Abstract

Abstract Introduction: Polycystic ovarian syndrome (PCOS) is the commonest cause of infertility due to anovulation. The combination of Curcuma longa (CL) and Emblica officinalis (EO) is known to ameliorate diabetes and, thereby, may resurrect PCOS. The present study aimed to evaluate the effect of this combination prepared by two different methods, independently and with metformin (Met), compared with Met in PCOS on glycaemic control, inflammation, adipokines, and anthropometry. Aim: The aim of the study was to evaluate the effect of the combination of CL and EO, prepared by two different methods, independently and with Met, compared with Met in PCOS. Materials and Methods: PCOS women aged 18–35 years were selected through Rotterdam criteria from a tertiary care teaching hospital setting post-Ethics Committee permission. They were randomized to five groups (eight per group); combination of CL and EO prepared by traditional method (TF- Traditional Formulation), standardized extraction method (PNAE- Pharmanza Nisha Amalaki Extract), standard control Metformin (M­et) and their combinations, TF + Met and PNAE + Met for 90 days. Fasting glucose, insulin, lipid profile, reproductive hormones (luteinizing hormone [LH], follicle-stimulating hormone [FSH], and free testosterone), inflammatory markers (tumor necrosis factor-alpha [TNF-α], interleukin [IL]-6), and adipokines (leptin and adiponectin) were done at baseline and day 90, whereas anthropometry was done monthly. Results: Of 48 randomized women, 37 completed the study. TF and Met groups demonstrated higher weight decrease, whereas TF + Met significantly decreased waist circumference. Blood glucose, insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) decreased in all groups except glucose in TF + Met and HOMA-IR in the Met group. Only PNAE decreased free testosterone. TNF-α increased while leptin decreased in all groups. Both TF and PNAE, with Met reduced IL 6, significantly only in PNAE + Met group. Similarly, both TF and PNAE, with Met reduced LH/FSH ratio and significantly increased adiponectin. Two females, each, conceived in TF and PNAE, whereas one was in PNAE + Met group. No adverse events were reported. Conclusion: Both botanical formulations, TF and PNAE, were comparable to Met. The standardized extracts formulation PNAE seems more promising due to administration ease, smaller dose, and consistent bioactives.