Clinical efficacy of a Unani formulation 'Safoof Habis' in menorrhagia: A randomized controlled trial

AimTo evaluate the efficacy and safety of Safoof Habis in Kasrate Tams (menorrhagia) with validated menstrual pictogram.Materials and methodsA single blind, randomized, standard controlled trial was conducted in the gynaecological outpatient of National Institute of Unani Medicine Hospital. Clinically diagnosed patients (n = 52) were randomized to the test (n = 35) and control (n = 17) groups. In the test group, Safoof Habis (Ingredient are Silicate of alumina and Iron oxide, Hydrated magnesium silicate and Vateria indica L.) 5 g twice daily and in the control group, tranexamic acid 500 mg, thrice daily were administered from day 1 to day 5 of menstrual cycle and Qurs Kushta Faulad, one tablet twice daily was administered in both the groups for three consecutive months. The primary outcome measure was to assess the efficacy and safety of this Unani formulation in menorrhagia with menstrual pictogram. The secondary outcome measures were to assess the effectiveness of test drug formulation on dysmenorrhea and hemoglobin concentration. The results were analyzed by Student's 't' test and Fisher exact test.ResultsThe groups were homogenous in the terms of age, parity, socioeconomic status, marital status and biochemical parameters (P > 0.05). Post treatment when compared to baseline in same group showed significant reduction in menstrual blood loss in both the groups (P < 0.001). The comparison between test and control group showed that both groups were equally effective (P = 0.265). There was improvement in hemoglobin concentration in the test group (P = 0.04) and dysmenorrhea was reduced in both groups (P < 0.001).ConclusionSafoof Habis was found to be effective in reducing menstrual blood loss in menorrhagia.