Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali
Phase 1b Clinical Trial Using Argemone Mexicana in Healthy Adults Infected or Not Infected With Plasmodium Falciparum in Mali: Pharmacokinetics and Observational Study
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2012
Shorter than P25 for phase_1
1 active site
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
First Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 3, 2012
October 1, 2012
1 month
July 3, 2012
October 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
health volunteers will be assessed daily for 3 days and then on Day 7 and then weekly up to 6 weeks.
6 weeks
Secondary Outcomes (1)
Plasma concentration curves of the drug
6 weeks
Study Arms (1)
Argemone mexicana
EXPERIMENTALArgemone 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.
Interventions
30g, the powder decoction 2 times a day for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bamakolead
- University of Geneva, Switzerlandcollaborator
Study Sites (1)
Malaria Research and Training Center, USTTB
Bamako, 1805, Mali
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Issaka Sagara, MD,MSPH
University of Bamako
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 20, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
October 3, 2012
Record last verified: 2012-10