Efficacy and Safety of Qurs-e-Bandish-e-Khoon in Heavy Menstrual Bleeding (Istehaza): A Double-Blind Randomized Standard Controlled Clinical Trial

Ethnopharmacological relevance : Heavy menstrual bleeding (HMB), clinically referred to as Istehaza in Unani medicine, significantly affects women’s physical, emotional, and social well-being. Conventional pharmacotherapies, though effective, are often associated with adverse effects. Qurs-e-Bandish-e-Khoon, a Unani formulation possessing haemostatic (Habis-i-Dam) and uterine-tonic (Muqawwi-e-Reham) properties, has been used traditionally in abnormal uterine bleeding. Despite its long-standing use, clinical evidence validating its therapeutic potential remains limited. Establishing its efficacy and safety through contemporary clinical evaluation is essential for integrating traditional ethnomedicinal knowledge into modern healthcare.Aim of the study: To evaluate the efficacy and safety of Qurs-e-Bandish-e-Khoon in comparison with Tranexamic acid in women with HMB. Materials and Methods: A double-blind, randomized, standard-controlled clinical trial was conducted on 50 eligible women aged 18–45 years presenting with HMB at the Department of Ilmul Qabalat wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre, Vijayapura, Karnataka, India. After obtaining written informed consent, participants were randomly allocated into two groups. The test group received Qurs-e-Bandish-e-Khoon (500 mg, two tablets twice daily for seven days starting from the first day of menstruation), whereas the control group received Tranexamic acid (500 mg, twice daily for seven days). Both interventions were administered for three consecutive menstrual cycles under close clinical supervision. The primary outcome measure was change in menstrual blood loss (MBL) assessed using the pictorial blood loss assessment chart (PBAC). Secondary outcome measures included changes in haemoglobin (Hb) level, cycle regularity, and overall symptom relief. Data were analysed using paired and unpaired t-tests, and p < 0.05 was considered statistically significant. Safety evaluation and adverse event monitoring were performed throughout the study.Results: Both groups showed a significant reduction in mean PBAC score was significantly reduced in both groups (p < 0.001). The observed mean difference in PBAC between Qurs-e-Bandish-e-Khoon and Tranexamic acid groups was −5.80 (p = 0.234, Cohen’s d = 0.28). Haemoglobin levels improved significantly within both groups (p < 0.01), though no intergroup difference was observed (p > 0.05). No adverse events or intolerance were reported during the study period.Conclusion: Qurs-e-Bandish-e-Khoon demonstrated comparable efficacy and safety to Tranexamic acid in reducing menstrual blood loss and improving haematological parameters in women with HMB. These findings support its potential as a safe, effective, and affordable Unani therapeutic option and reinforce the ethnopharmacological value of traditional Unani haemostatic formulations.