MedTrace Logo

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

NCT04944966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Maytenus Senegalensis

* 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

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Ifakara Health Institute

    lead OTHER

Principal Investigators

  • Kamaka Kassim, BscN,MPH · Ifakara Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-09-25
Completion
2022-09-25

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944966 on ClinicalTrials.gov