A novel herbal combination ameliorates ovarian dysfunction and regulates altered biochemical parameters in rats with letrozole-induced polycystic ovary syndrome

Objective: To investigate the potential activity of novel herbal combination and novel herbal formulation (syrup) in female Sprague Dawley rats with letrozole-induced polycystic ovary syndrome (PCOS). Methods: Forty-two rats were randomly divided into seven groups with six rats in each group. Group 1 received 0.5% carboxy methylcellulose orally for 37 days and served as the normal control group. Group 2 was orally administered with letrozole of 1 mg/kg for 21 days and served as the PCOS induction group without treatment. Group 3 to 7 were administered with letrozole of 1 mg/kg for 21 days orally to induce PCOS, and then respectively received clomiphene citrate at 1 mg/kg, 100 and 200 mg/kg of novel herbal combination, 200 mg/kg of novel herbal formulation (syrup), and 400 mg/kg of marketed formulation of Pushyanuga churna, once daily for 15 days. Effects of the novel herbal combination and its syrup formulation were evaluated on the hormonal profile, the levels of antioxidants, the lipid profile and on the ovarian morphology, using letrozole-induced PCOS model in rats. Results: Letrozole caused alterations in hormonal levels and lipid levels similar to PCOS and ovarian histology showed presence of ovarian cysts confirming the induction of PCOS in rats. On treatment with the novel herbal combination and its syrup formulation in PCOS-induced rats, the altered hormonal and lipid profiles showed significant recovery to normal levels. Ovarian histology confirmed the restoration of folliculogenesis in the PCOS-induced rats. The treatment with the syrup formulation of novel herbal combination was found to be more effective than novel herbal combination and showed better recovery in various parameters evaluated. The results of the study, however, suggested that treatment with novel herbal combination and its syrup formulation provided minimal protection against oxidative stress caused due to the induction of PCOS. Conclusions: The integrated approach for management of PCOS is to counterbalance the limitations associated with modern therapy. Both the novel herbal combination and the syrup formulation of novel herbal combination show efficacy in the management of PCOS in rats and restore folliculogenesis in the ovary. The syrup formulation of novel herbal combination is most effective in the management of PCOS and shows potential to be developed as an adjuvant therapeutic agent.