This trial is active, not recruiting.

Condition malaria
Treatment argemone mexicana
Phase phase 1
Sponsor University of Bamako
Collaborator University of Geneva, Switzerland
Start date September 2012
End date October 2012
Trial size 24 participants
Trial identifier NCT01645254, MRTC_Arge01


The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Argemone mexicana is traditional medicinal plant known as having an antimalarial activity. The aerial part of this plant is used. The decoction of the powder of the plant will be used.
argemone mexicana traditional antimalarial
30g, the powder decoction 2 times a day for 14 days

Primary Outcomes

Number of Adverse Events
time frame: 6 weeks

Secondary Outcomes

Plasma concentration curves of the drug
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - age of 18-50 years old; - be in good general health; - be available for the duration of the study; - agreement to participate in the study - be a resident of the village known study; - acceptance of the conservation laboratory specimens for future research. Exclusion Criteria: - Plasmodium falciparum infection with clinical manifestations; - Presence of severe or complicated malaria; - Acute medical condition; - Any other medical condition that requires medical attention inconsistent with the study or interfere with the study; - Severe medical conditions; - Allergy to the product of the study, - Pregnant women or nursing - Taking a derivative product of the study or other known antimalarial within 14 days before enrollment. - Refusal to participate

Additional Information

Official title Phase 1b Clinical Trial Using Argemone Mexicana in Healthy Adults Infected or Not Infected With Plasmodium Falciparum in Mali: Pharmacokinetics and Observational Study
Principal investigator Issaka Sagara, MD,MSPH
Description This is an open non comparative safety and pharmacokinetic (PK) study clinical trial. Healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current World Health Organization malaria drug protocol efficacy assessment protocol. Each volunteer will be take oral Argemone mexicana in decoction formulation. For the PK assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days Safety will be assessed clinically (Clinical exam and Electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Bamako.