EFFICACY AND SAFETY OF "SACHI SAHELI" POLYHERBAL FORMULATIONS IN GYNAECOLOGICAL DISORDERS: A PROSPECTIVE, NON-RANDOMISED, OPEN-LABEL STUDY

Abstract

Background and aim: Symptoms of gynaecological disorders, including dysmenorrhea, leukorrhea, and premenopausal syndrome (PMS), are a common health concern, particularly among women of reproductive age. Due to the adverse effects of conventional treatments, the use of herbal remedies to treat various gynaecological disorders has increased. This study aimed to assess the efficacy and safety of Sachi Saheli formulations in subjects suffering from dysmenorrhea, leucorrhoea, and PMS. Methods: This was a single-arm, open-label, non-randomised prospective study. Female participants were recruited based on the inclusion and exclusion criteria. Study interventions were given to all participants for 90 days. Changes in blood haemoglobin levels were assessed from the baseline to the end of the study. Subjective symptoms and the investigators' severity assessment on 27 questionnaires were evaluated at baseline and the end of the study. Safety was also assessed by measuring liver and kidney function's haematological and biochemical markers. Results: A total of 120 female subjects were enrolled. After treatment with Sachi Saheli syrup and tablets, blood haemoglobin levels increased significantly compared to baseline (p < 0.0001). All subjects showed significant improvement in anxiety, menstrual pain, depression, and vaginal discharge symptoms. A significant improvement in the severity of physical and affective symptoms across 27 parameters was also observed. There were no significant changes observed in laboratory safety parameters. None of the subjects reported any adverse events during the treatment period. Conclusions: Sachi Saheli syrup and tablet may improve the symptoms of dysmenorrhea, leukorrhea and PMS.