A clinical trial to evaluate the efficacy and safety of alpha,beta-arteether in patient of P. falciparum malaria.
- Conditions
- Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
- Registration Number
- CTRI/2010/091/000169
- Lead Sponsor
- incoln Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Written informed consent from the patient.
2.Male and Female patients with aged 18 years above inclusive.
3. Diagnosis of Patients with P. falciparum malaria by the presence of ring forms of P. falciparum in thick and thin peripheral blood smears (parasitemia > 5%).
1. Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
2. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
3. Known hypersensitivity to alpha,beta-arteether.
4. Patient with renal failure and other systemic disorder.
5. Patient who is consuming/ has received drugs, which have interaction with alpha,beta-arteether, during last 14 days.
6. Participation in any other clinical trial during last 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Cure rateTimepoint: after 3 days
- Secondary Outcome Measures
Name Time Method Parasite clearance timeTimepoint: Based on blood smear test after drug administration of 24 hours, 48 hours and 72 hours