Efficacy of Unani Formulation in Bawāsīr-i-Ghāyra (Internal Haemorrhoids) of the First and Second Degree: An Observational Clinical Study

Abstract Background: Hemorrhoidal disease is a common proctological disorder which creates physical as well as psychological disturbances and affects the quality of life. The Ḥab prepared from Halaila kāblī, Kahrubā Shama‘ī, Muqil, Āb-i-Gandanā , and Roghan-i-gāo has a specific action in the treatment of Bawāsīr-i-Ghāyra (internal hemorrhoids). It has the property of evacuation of Sawdā and is hemostatic as well as laxative. Aim: The present study aimed to evaluate the effect of Unani Formulation in Bawāsīr-i-Ghāyra ↱ of the first and second degree. Materials and Methods: Thirty patients of 1 st and 2 nd -degree internal hemorrhoid who fulfilled the protocol criteria were enrolled for an observational clinical study from June 2019 to Feb 2020. Patients were given Unani formulation in the form of Ḥab and instructed to take 4 Ḥab (580 mg each), orally thrice daily for 45 days. The efficacy outcome was assessed by an arbitrary grading scale. The outcomes were analyzed using appropriate statistical methods. The safety was assessed by employing pertinent biochemical parameters and reporting adverse drug reactions. Results: Data analysis showed improvement in subjective parameters; there was 100% relief in bleeding per rectum ( P < 0.001), 16.7%, improvement in mucus discharge per rectum ( P = 0.251), and 33.3% improvement in itching per rectum ( P = 0.077) at the end of the treatment. The objective parameter bleeding point showed an improvement of 56.7% ( P < 0.001) and for the sphincter spasm improvement of 30.0% ( P = 0.103) at the end of the trial. No significant changes in biochemical indices between pre- and post-treatment were recorded. No adverse drug reactions were reported throughout the study period. Conclusion: The result inferred that the test drug is safe and effective in improving the severity of symptoms of first and second-degree Bawāsīr-i-Ghāyra and can be used as an alternative to conventional treatment. However, further studies with control and a larger sample size are needed to ascertain the study findings.