A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria
- Conditions
- Malaria
- Registration Number
- ITMCTR1900002588
- Lead Sponsor
- Guangzhou University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Age: 6 months to 60 years old;
2. Uncomplicated falciparum malaria in microscopic examination;
3. The number of asexual protozoa is 2000–200 000/µL in high malaria endemic areas,and is 1000–100 000/µL in low malaria endemic areas;
4. Axillary temperature>= 37.5 degree C or had fevered in 24 hours
5. Having ability to swallow oral medication;
6. Having ability and willingness to abide by the protocol during the study and following the study follow-up;
7. If the patient is a child, should obtain informed consent form from the parent or guardian.
1. According to the definition of WHO(2000), children under 5 years old with general signs of danger or symptoms of severe falciparum malaria;
2. Mixed malaria patients in microscopic examination;
3. According to the WHO (2006) Child Growth Standard, severely malnourished children;
4. Fever caused by measles, acute lower respiratory tract infection, severe diarrhea with dehydration, other known chronic or serious diseases (such as heart, kidney or liver disease, AIDS) expect malaria
5. Other routine medications that interfere with pharmacokinetics of antimalarial drug
6. Allergic reactions or contraindications to any drug being tested or used as an alternative treatment of the disease;
7. Pregnancy test positive or lactating women;
8. Women of childbearing age who are unable or unwilling to take contraceptive measures.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood concentration;Susceptibility test of Plasmodium falciparum in vitro;Hematocrit;Electrocardiogram;leukocyte;Urine examination;Blood chemistry;Molecular marker detection for antimalarial drug resistance;Plasmodium Density;Pregnancy test;Hemoglobin;
- Secondary Outcome Measures
Name Time Method