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A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria

A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002588
Enrollment
Unknown
Registered
2019-09-11
Start date
2019-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Sponsors

Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 60 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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;

Countries

Union of Comoros

Contacts

Public ContactSong Jianping

Guangzhou University of Chinese Medicine

songjp@gzucm.edu.cn+86 020 36585633

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026