Effect of Leech Therapy (Irsal-e Alaq) and Unani Formulation (Itrifal Sagheer with Zanjabeel) in the Management of Varicose Veins (Dawali): An open, randomized, standard controlled, three groups clinical trial

Abstract

Background and Objectives: Varicose veins affect up to 5% or more of the adult population of western countries and 15 to 20% of general population. The inability to perform heavy and prolonged standing works affects the quality of life, and earning capacity of patients as well. Unani physicians have described this disease as Dawali and have been treating the disease since ancient times effectively on the principle of evacuation (Tanqiya), restoration (Ta’deel) and potentiation (Taqwiyat). The limitation of conventional treatment in the management of varicose veins paved the way to evaluate the efficacy and safety of leech therapy and a pharmacopoeial Unani poly herbal formulation in the management of varicose veins on scientific parameters. Methods: The study was conducted as open, randomized, standard controlled, three groups clinical trial on 30 eligible patients. Leech therapy was selected as a treatment procedure in the test group ‘A’. The combination of Unani formulation Itrifal Sagheer with Zanjabeel and leech therapy was selected as a treatment strategy in the test group ‘B’. Compression stocking was selected as a standard treatment procedure in the control group ‘C’. Results: Significant statistical difference was observed in subjective and objective parameters. Almost all patients reported improvement in pain and heaviness. The more promising result was observed in group ‘A’ in pain (82%), where group ‘B’ showed more marked response (64%) in heaviness among all the groups. In intra group comparisons, statistically highly significant difference was observed from baseline to 14th day to 28th day (P