Laboratory Studies and Clinical Trials on New Formulations from Garlic Extract Against Cutaneous Leishmaniasis

Azam      J. Samdani; Samreen; M.      Iqbal Choudhary; Atta-ur-Rahman

doi:10.2174/2211362611208020111

Abstract

Leishmaniasis is a global disease, which has become a major health challenge for Pakistan and other developing countries. Infections caused by the parasitic protozoa constitute a major hindrance in socioeconomic development in many developing countries. In this study, we developed a topical application (gel), containing active ingredients derived from garlic, on which in vitro, in vivo, and clinical studies were conducted. Anti-leishmanial activity observed in vitro was followed by in vivo study with the application of this active ingredient, prepared in gel form, and applied once daily on experimental mouse model. Their lesions cured completely within 4-6 weeks. This was followed by clinical trials in humans. A total of 70 patients, 58 (82.85%) males, and 12 (17.14%) females, were selected with positive Leishmania parasites by smear examination. Out of 70 patients, 57 patients (81.42%) responded to the treatment, while 13 patients (18.57%) did not. Ten patients (17.54%) showed complete clinical recovery after 06 weeks of therapy, while 40 (70.17%) showed complete clinical recovery after 08 weeks of therapy. The results of this clinical study establish the efficacy, and cost effectiveness of garlic-based topical gel, and pave the way for further research in its therapeutic applications.

Keywords: Leishmaniasis, cutaneous leishmaniasis, clinical trials, garlic extract, topical applications, anti-leishmanial activity, In vitro studies