NCT07819825

Brief Summary

The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is: Can Artemisia annua infusion be used to treat malaria? Researchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion. Participants will

  • drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home
  • visit the research centre once a week for three weeks after treatment for one month for safety reasons

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Jun 2027

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 15, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

Plasmodium falciparumArtemisia annuainfusion

Outcome Measures

Primary Outcomes (1)

  • Number of participants in whom the parasitaemia was cleared

    No parasites detected in the thick blood smear (microscopic method)

    On day 7 from the first day of treatment

Secondary Outcomes (2)

  • Number of participants cured

    From the last day of treatment (day 7) to the end of the follow-up period on day 28

  • Number of adverse events

    From the first day of treatment (enrolment) to the end of the treatment period on day 7

Study Arms (2)

Artemisia arm

EXPERIMENTAL
Drug: Artemisia Annua Leaf

Control arm

PLACEBO COMPARATOR
Drug: Centaurii herba

Interventions

Dried Artemisia annua leaves will be used to prepare an infusion by adding 5 mg of dried leaves to 1 litre of boiled water. The mixture will be left to stand for 15 minutes, then stirred and strained before being administered to the participant. Participants will receive 1 litre of this infusion (prepared each morning) per day for seven consecutive days. The research team will administer the daily dose in three splits at 8-hour intervals.

Artemisia arm

The research team will prepare one litre of 'Herba Centaurii' infusion every morning, which will be given to the participants in three splits every 8 hours, under the supervision of the research team for seven consecutive days.

Also known as: Centaurium erythrea
Control arm

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 to 45 years
  • Absence of fever (body temperature \<37.5ºC axillary or \<38.0°C oral, rectal or tympanic temperature)
  • Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood
  • Have been living in an endemic area for at least 5 years.
  • Written informed consent from the participant
  • Residence in the vicinity of the study centre
  • Willingness to comply with the follow-up schedule

You may not qualify if:

  • History of fever over the last 72 hours
  • Non-Plasmodium falciparum infection
  • Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and/or after half-life time
  • Presence of signs and symptoms related by the medical doctor to malaria
  • Known history or evidence of clinically significant medical disorders
  • Severe malnutrition
  • Haemoglobin concentration \<7 g/dL
  • Known hypersensitivity and contraindications to any study medication
  • Pregnancy or lactation
  • Participation in other interventional studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Gabon, BP: 242, Gabon

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Steffen Borrmann, Prof.

    Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany

    STUDY CHAIR
  • Ayôla Akim Adegnika, Prof.

    Centre de Recherches Médicales de Lambaréné

    STUDY CHAIR

Central Study Contacts

Jean Claude Dejon Agobé, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-08

Locations