Last reviewed · How we verify

NCT04944966: MALHERBAL

Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria

Completed Phase 2 Last updated 18 July 2023
What this trial tests

Phase 2 trial testing Maytenus Senegalensis in Malaria in 12 participants. Completed in 25 September 2022.

Timeline
2 June 2021
Primary endpoint
25 September 2022
25 September 2022

Quick facts

Lead sponsorIfakara Health Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment12
Start date2 June 2021
Primary completion25 September 2022
Estimated completion25 September 2022
Sites1 location across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

Ifakara Health Institute

Who can join

Adults 18 to 45, male only, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effect of an anti-malarial herbal remedy, Maytenus senegalensis, on electrocardiograms of healthy Tanzanian volunteers.
    Kassimu KR, Ali AM, Omolo JJ, Mdemu A, et al · · 2024 · cited 3× · PMID 38609987 · DOI 10.1186/s12936-024-04935-w
  2. Safety and Tolerability of an Antimalarial Herbal Remedy in Healthy Volunteers: An Open-Label, Single-Arm, Dose-Escalation Study on <i>Maytenus senegalensis</i> in Tanzania.
    Kassimu K, Milando F, Omolo J, Mdemu A, et al · · 2022 · cited 3× · PMID 36548651 · DOI 10.3390/tropicalmed7120396
  3. Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour.
    Kassimu KR, Milando FA, Omolo JJ, Nyaulingo G, et al · · 2022 · cited 2× · PMID 35862395 · DOI 10.1371/journal.pone.0271828

Verify or expand the search:

Other recruiting trials for Malaria

Currently open trials in the same condition.

Other Ifakara Health Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04944966.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing