Evaluation of safety and efficacy of Maytenus senegalensis for the treatment of uncomplicated malaria episodes in adult patients as compared to Artemether-lumefantrine

Malaria is a disease of poverty and still a major global health problem, especially in Africa. Almost all African countries are located in a malaria-endemic area. It was estimated that 228 million cases of malaria occurred worldwide in 2018 and most of these cases came from Africa. Tanzania is among the top ten countries with the highest burden of malaria in the world.

The development of insecticide and artemisinin resistance threatens the gains that have been made in the control and elimination of malaria. Therefore, the scientific investigation of antimalarial herbal remedies to prove their safety and efficacy might be of benefit to the worldwide agenda of malaria control and elimination.
This study aims to address a critical need in malaria control in Africa and to identify new malaria treatment products that can counter the emergence of antimalarial resistance in South East Asia. This study will demonstrate a new development strategy for identifying novel antimalarial drugs through exploiting the rich, natural biodiversity of Africa. Clinical evaluation of the medicinal potential of herbal products may fast track finding solutions for Africa’s malaria and other health problems.

The first primary objective of this study will be to assess the safety and tolerability of malaria herbal remedy of Maytenus senegalensis (MALHERBAL) among healthy male adults aged 18 to 45 years in Tanzania. And the second objective is to evaluate the safety, tolerability as well as the efficacy of malaria herbal remedy Maytenus senegalensis (MALHERBAL) for the treatment of Tanzanian adults aged 18 to 45 years with uncomplicated malaria compared to Artemether-lumefantrine.

The study will comprise two study designs that depend on these two study groups. The design for study group 1 is an open-label, dose-escalation study evaluating the safety and tolerability of Maytenus senegalensis among 12 healthy male adults aged 18 to 45 years in Tanzania. The study population will be given Maytenus senegalensis and followed up for safety for 56 days.

The decision to proceed from G1 to the enrolment of G 2 participants will be determined by an independent safety monitoring committee (SMC) after reviewing pre-specified “go or no go” criteria. These criteria will be based on safety data obtained from 12 participants of study group 1 on day 28 after the first treatment.
The design for study group 2 is a single-center Phase IIa open-label, safety assessment, and a 2-arm randomized, controlled study.

The design will be used for the evaluation of safety, tolerability, pharmacokinetics as well as the efficacy of Malaria herbal remedies for the treatment of malaria episodes among male adults aged 18 to 45 years with uncomplicated P. falciparum malaria, compared to Artemether-lumefantrine in Tanzania. The first is Group 2a of 52 patients will be treated with the Maytenus senegalensis while G2b of 52 patients will be treated with Artemether-lumefantrine. Patients will be followed up for 56 days. In the presence of treatment failure during the follow-up, the rescue treatment will be used.

The follow-up duration for every participant is 56 days after admiration of the tested product and the duration of the entire study will be expected to be 12 months. The ARCAD has been supported by the Rudolf Geigy Foundation since August 2018 to implement the evaluation of an herbal antimalarial Maytenus senegalensis in Tanzania. #