A study to determine the effectiveness of two drugs Chloroquine and Primaquine in P.vivax malaria in Kolkata
- Conditions
- Health Condition 1: null- Malaria
- Registration Number
- CTRI/2011/09/002031
- Lead Sponsor
- Department of Health and Family Welfare Govt of West Bengal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
According to WHO Protocol 2009
Inclusion criteria
age over 6 months
mono-infection with P. vivax detected by microscopy
asexual parasite count 1000 â?? 1,00,000/µl
axillary temperature >= 37.5 °C or history of fever during the 48 h before recruitment
ability to swallow oral medication
ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
informed consent from the patient or from a parent or guardian in the case of children
absence of a clinical condition due to vivax malaria (coma, respiratory distress syndrome or severe anaemia) requiring hospitalization
absence of severe malnutrition according to WHO child growth standards
absence of a febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or ystemic disease (e.g. cardiac, renal or hepatic disease, HIV/AIDS).
absence of regular medication, which might interfere with anti-malarial pharmacokinetics
Exclusion criteria
Presence of one or more of the general danger signs or any sign of severe or complicated malaria
Presence of mixed infection
Presence of severe malnutrition
Presence of febrile conditions caused by diseases other than malaria
Presence of a severe disease
Contraindication related to anti-malarial drugs used, specially h/o allergy
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method