A prospective comparative field study to evaluate the efficacy of a traditional plant-based malaria prophylaxis.

Background: An unceasing threat of resistance of malarial parasites to available antimalarial drugs makes the development of new drugs imperative. Natural plant-based products are an alternative source for discovering new antimalarial drugs. Aim: To determine the prophylactic efficacy of a traditionally used plant-based drug on prevention of malaria in endemic villages of Odisha, India. Methods: A total of 267 healthy human volunteers of both sexes, aged 18-60 years were enrolled in Odisha, India, to receive either minimum 20 doses of aqueous extract of Traditional Plant-based Malaria Prophylactic drug 74, twice a week (experimental group), or no drug (control group) for 14 weeks. The primary criterion was the occurrence of malaria positive cases confirmed through expert microscopy during the study period. Analyses were by per-protocol (PP) and modified intention-to-treat (mITT). Results: A significant (P < 0.01) reduction (64%) of malaria incidence was observed in the experimental group compared to control group, 12.3% and 26.6%, respectively, as PP analysis. However, the reduction was nonsignificant as per mITT analysis (P = 0.22). The experimental group showed a relative risk of 0.36 compared to control group. Conclusion: This preliminary study constitutes a potential "proof of concept" for the development of malaria prophylactic drug and provide a scientific basis for the use of traditional remedy as a malaria preventive by tribal populations in India.