About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Artemisia Annua Leaf
DrugDried 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.
Centaurii herba
DrugThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants in whom the parasitaemia was cleared
No parasites detected in the thick blood smear (microscopic method)
Secondary outcomes
Number of participants cured
Defined as the absence of Plasmodium infection (including reinfections) following treatment, as determined by microscopy and adjusted by PCR, in the per-protocol and intention-to-treat populations.
Number of adverse events
Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety
Sponsors and contacts
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Centre de Recherche Médicale de Lambaréné
Lead sponsor
Institute of Tropical Medicine, University of Tuebingen
Collaborator
This trial is not recruiting at the moment. You can still explore other options: