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A clinical trial to evaluate the efficacy and safety of alpha,beta-arteether in patient of P. falciparum malaria.

A Phase III, Multicenter, Open Label, Randomized, Single Treatment study to evaluate the efficacy and safety of alpha,beta - arteether injection 150 mg/mL in patient of P. falciparum malaria.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000169
Enrollment
200
Registered
2010-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B509- Plasmodium falciparum malaria, unspecified

Interventions

Intervention1: Arteether Injection: One injection once daily for atleast three days Control Intervention1: NIL: NIL

Sponsors

Lincoln Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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%).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Mean Cure rateTimepoint: after 3 days

Secondary

MeasureTime frame
Parasite clearance timeTimepoint: Based on blood smear test after drug administration of 24 hours, 48 hours and 72 hours

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

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