ITMCTR1900002588
Not yet recruiting
Phase 4
A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria
ConditionsMalaria
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Guangzhou University of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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