Effect of Primaquine in the patients of P.vivax and P.falciparum malaria.
- Registration Number
- CTRI/2010/091/001040
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Patients with confirmed cases of vivax and falciparum malaria (asexual forms) by microscopy on a thin blood smear (parasite density >300/mm3)
-Patients giving written informed consent to participate in this study.
-Male and female patients aged 18 -65 years.
-Patients with axillary temperature >37.50C (>99.50F)
-Patients with chills, nausea, vomiting, headache, malaiase and any 2 of the following signs/symptoms of uncomplicated malaria (diarrhea, anorexia, abdominal cramps, myalgia, arthralgia)
-Normal G-6-P-D status as assessed by qualitative and quantitative tests.
-Patients with history of hypersensitivity to chloroquine, quinine, primaquine or aminoquinoline derivatives or other similar drugs as assessed by history.
-Pregnant (female patients with prescribed pregnancy test positive) or lactating women.
-Patients with severe or complicated malaria or mixed malarial infection.
-Patients taking cardioactive drug or potentially hemolytic drugs or bone marrow depressants.
-Patients on another investigational drug.
-Patients with concomitant illness (cardiac, hepatic or renal diseases)
-Patients previously treated with any other antimalarial therapy except chloroquine
-Patients with glucose 6-phosphate dehydrogenase deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the pharmacokinetic parameters of primaquine in patients suffering from P.vivax and P.falciparum malaria. (Cmax, tmax, AUCss,t, t1/2)Timepoint: Day 1, 2, 3 and 14
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil