None listed
Conditions
Interventions
Intervention1: RPM02/08: 500mg 3 times a day for 7 days orally
Control Intervention1: DUMMY-RPMD02/08: 500mg 3 times a day for 7 days orally
Sponsors
Medical &Research Center-Kasturba Health Society
(MRC-KHS) 17, Khandubhai Desai Road, Vile Parle (West),
Mumbai 400 056, Phone: 91 22 2615417
E-mail: mmrckhs@gmail.com
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria ? Adult males or females aged between 18 and 60 years of age with a diagnosis of P vivax malaria ? Diagnosed as having malaria as indicated below o Blood smears positive for P. vivax (Parasite count >1000parasites/ µl of blood), o Fever or history of fever (≥ 37.5 oC/99.5oF axillary or 38oC/100.4oF orally ) ? Hemoglobin more or equal to 8 gm/dl
Exclusion criteria
Exclusion criteria: Exclusion Criteria: ? Patients with diagnosed P. falciparum and /or mixed infections. ? Patients with severe malaria as per WHO criteria ? Evidence of severe hepatic, renal, cardiac or metabolic diseases ? Patients with recent stroke or unstable angina or myocardial infarction or cardiac failure in previous 6 months. ? Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug. ? Known allergy and adverse effect of Chloroquine and/or Parijat preparation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are ? The clinical tolerability and organ function safety in concurrent with Chloroquine therapy ? To evaluate the differences in clinical responses between the 2 groups Timepoint: At the end of 1 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are ? To study the effect of addition of RPM 02/08 TO Chloroquine on the markers of severity of malaria ? To assess the difference in parasitic response between the 2 groups. Timepoint: At the end of 1 month | — |
Countries
India
Contacts
Public ContactDr Rama Vaidya
Dean
Outcome results
None listed