MalariaPhase 1NCT01645254
Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali
A Phase 1 study testing Argemone mexicana in people with Malaria, run by University of Bamako at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Argemone mexicana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMali
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Pregnant women or nursing
- Taking a derivative product of the study or other known antimalarial within 14 days before enrollment.
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Malaria
- Being tested
- Argemone mexicana
- Keywords
- healthy volunteers, pharmacokinetics, malaria, Argemone mexicana
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argemone mexicanaDrug
Also called traditional antimalarial
30g, the powder decoction 2 times a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Argemone mexicana | Experimental | 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. Receives: Drug: Argemone mexicana |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Plasma concentration curves of the drug
The phramacokinetics measured will be performed depending on the treatment groups. Three different treatment groups have constituted, each group will be allocated a specific time point for PK assessment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bamako
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, Issaka Sagara, M.D., MSPH, University of Bamako
- Investigators
- Issaka Sagara, MD,MSPH, Principal investigator, University of Bamako
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645254
- Sponsor's protocol ID
- MRTC_Arge01
- Other IDs
- MRTC_Arge01
- Status last verified
- Oct 2012
- First submitted
- 3 Jul 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01645254
- Acronym / sponsor ID
- MRTC_Arge01
- Conditions
- Malaria
- Keywords
- healthy volunteers, pharmacokinetics, malaria, Argemone mexicana
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BamakoUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argemone mexicana | Experimental | Drug: Argemone mexicanaArgemone 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argemone mexicanaAlso: traditional antimalarial30g, the powder decoction 2 times a day for 14 days | Drug | Argemone mexicana |
Primary outcome
Number of Adverse Events
Time frame: 6 weeks
health volunteers will be assessed daily for 3 days and then on Day 7 and then weekly up to 6 weeks.
1 secondary outcome
Plasma concentration curves of the drug
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issaka Sagara, MD,MSPH principal investigator
University of Bamako
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Argemone mexicana in people with Malaria, run by University of Bamako at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.