Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Antimalarial Herbal medicine known as Maytenus senegalensis will be evaluated for its safety,
      tolerability and efficacy among Tanzanian male adults aged 18 to 45 years. The first primary
      objective is to assess the safety and tolerability of malaria herbal remedy of Maytenus
      senegalensis among healthy male adults aged 18 to 45 years in Tanzania. And the second
      objective is to evaluate the safety, tolerability as well as 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.
    

Detailed description: 
      The herbal medicine (Maytenus senegalensis) has been scientifically investigated for acute
      toxicity in vitro and antiplasmodial activity both in vitro and in vivo where it showed
      strong antimalarial activity. However, to our knowledge, no antimalarial studies have been
      performed on this herbal medicine in standardized clinical settings.

      The study will contain two treatment groups. Group 1 will have 12 healthy male adults aged 18
      to 45 years who will be given the malaria herbal remedy (Maytenus senegalensis) and followed
      up for safety for 56 days. The subgroup 1a will be the first group to be enrolled in the
      study and given Malaria herbal remedy. The safety assessment of this group will be done in 7
      days after the first treatment. If there will be no major safety concern per-protocol among
      participants of group 1a, the subgroup 1b participants will be enrolled in the study and
      given Malaria herbal remedy. The safety assessment of this subgroup 1b will be done 7 days
      after the first treatment. If there will be no major safety concern per-protocol among
      participants of group 1b, the subgroup 1c participants will be enrolled in the study and
      given Malaria herbal remedy. The safety assessment of this subgroup 1c will be done 7 days
      after the first treatment. If there will be no major safety concern per-protocol among
      participants of group 1c, the subgroup 1d participants will be enrolled in the study and
      given Malaria herbal remedy. The decision to proceed from G1 to the enrolment of G 2
      participants will be determined by pre-specified "go or no go" criteria.

      Study group 2 will comprise two subgroups of male Adults aged 18 to 45 years with
      uncomplicated malaria. The first is study group 2a of 52 uncomplicated malaria patients who
      will be treated with the malaria herbal remedy (Maytenus senegalensis) while G2b of 52
      uncomplicated malaria patients will be treated with Artemether-lumefantrine. Patients will be
      followed up for 56 days. In the presence of failure for either the herbal remedy and
      Artemether-lumefantrine and Early Treatment Failure criteria met, the rescue treatment will
      be used.

      The purpose of utilizing Group 1 participants is to assess the safety and tolerability of
      Maytenus senegalensis and proof of the concept that the herbal product is safe for the human
      subject. Therefore, the decision to proceed to Group 2 intervention for patients with
      naturally acquired malaria will be subjected to pre-specified "go or no go" criteria. These
      criteria will be based on safety data obtained from the sentinel group of 12 participants on
      day 28 after the first treatment and will be reviewed by an independent safety monitoring
      committee (SMC) appointed for this study. If one of the following criteria will be met, the
      study will not enroll the remaining G2 participants: (i)Any SAE related to the antimalarial
      herbal remedy (ii) ≥50% of the participants experienced a Grade 3 AR persisting at Grade 3
      for > 48 hours during the 14 follow-up days.
    

Intervention name(s): Maytenus Senegalensis
Intervention type(s): Drug
Intervention description(s): Maytenus senegalensis (Malherbal) has a very long history of safe medicinal use in Africa in adult as well as infants and children. It will be administered orally at a dose of 800mg 8 hourly for 4 days.
Artemether 20mg/lumefantrine 120mg
Other intervention name(s): Artemether-lumefantrine
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment