Clinical evaluation of safety and efficacy of Habb-e-Bawaseer Damiya in Bawāsīr Dāmiya (bleeding piles): A preliminary study

Introduction: Bawāsīr Dāmiya (bleeding piles) is a common health disorder in today’s fast-paced life. The Unani system of medicine offers many single and compound formulations for the safe management of bleeding piles. Objective: This study aims to evaluate the safety and efficacy of the Unani pharmacopoeia formulation Habb-e-Bawaseer Damiya in patients with Bawāsīr Dāmiya (bleeding piles) as a conservative treatment. Materials and Methods: This study was a single-arm, open-label trial involving 73 clinically diagnosed cases of Bawāsīr Dāmiya (bleeding piles), aged 18–65 years, of either sex, who signed the informed consent form and adhered to the protocol. The patients were administered the Unani formulation, specifically one pill of Habb-e-Bawaseer Damiya taken orally twice daily with water for 2 weeks, with two follow-ups. Assessments of subjective and objective parameters were conducted weekly and recorded in the CRF. The results were expressed in terms of the percentage of efficacy calculated from the Visual Analog Score and analyzed statistically. Results: Subjective parameters such as rectal bleeding, mucus discharge, pruritus ani, and rectal pain decreased significantly ( P < 0.001) by 54.95%, 54.58%, 48.37%, and 50.75%, respectively, compared to baseline. No significant adverse changes were observed in safety parameters during or after the trial. Conclusion: It can be concluded that the Unani formulation Habb-e-Bawaseer Damiya is safe and effective for treating Bawāsīr Dāmiya .