EVALUATION OF EFFICACY AND SAFETY OF MAMA ANTIMALARIAL HERBAL TABLETS IN ADULTS WITH UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA: A PILOT RANDOMISED CONTROLLED TRIAL

Abstract

Background: Malaria, caused by Plasmodium falciparum in humans, is a major cause of morbidity and mortality, especially in sub-Saharan Africa. Herbal preparations for the management of malaria are available in different cultures. MAMA Antimalarial Herbal Tablets (MAHT) were prepared by direct compression from MAMA Powder, which is an herbal antimalarial product already patented and listed for the treatment of malaria in Nigeria. The study evaluated the efficacy and safety of the tablets and compared them with those of Artemether-Lumefantrine tablets in uncomplicated Plasmodium falciparum-infected adults.

Methods: This was a pilot, open-label, randomised controlled Phase II clinical trial. Ten patients with uncomplicated malaria were randomised into each of the two arms of the study using computer-generated random numbers. Ten received MAMA Antimalarial Herbal Tablets (MAHT) and 10 received artemether-lumefantrine (AL). Patients' biodata and clinical information were collected using a proforma. Malaria parasite density was assessed on Days 0, 3, 5, and 7. Safety assessment was done on Days 0, 3 and 28 by measuring haematological, liver and renal function parameters. The data were analysed using SPSS version 25.

Results: Twenty participants were enrolled. Parasite clearance was progressive in both groups, with parasite positivity in the MAHT group declining from 100% at baseline to 80% on Day 3, 20% on Day 5 and 0% on Day 7. In the AL group, parasite positivity declined from 100% at baseline to 80% on Day 3 and 0% on Days 5 and 7. There was no statistically significant difference in parasite clearance between the two groups (p>0.05). There was a significant increase in albumin and conjugated bilirubin in the MAHT group on Day 3 and a decrease in haemoglobin in both groups on Day 28, but there was no consistent pattern of laboratory deterioration suggestive of clinically important toxicity in either of the treatment groups.

Conclusion: This pilot study provides a signal of antimalarial activity of MAHT, with progressive parasite clearance observed through Day 7. The serial haematological, hepatic and renal assessments showed tolerability of the antimalarial herbs, but the small sample size precludes firm conclusions regarding efficacy and safety. These preliminary findings require a larger multicentre study to affirm and ratify our experimental outcomes.