A Phase III, Multicenter, Randomized study to examine effectiveness, safety, and tolerability of Zintrodiazine in patients with Uncomplicated Plasmodium Vivax Malaria

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Zintrodiazine: Dose : 900 mg Route: Oral Frequency : Single Dose Duration: Single Dose Control Intervention1: Lariago‐DS: Dose : 500 mg Route: Oral Frequency :two tablets followed by two tablets 24 h and one tablet 48 h post‐first‐dose (total course of 5 tablets) Duration : 3 days CONDITION: Health Condition 1: B519‐ Plasmodium viva Xmalaria without complication PRIMARY OUTCOME: To evaluate the efficacy of Zintrodiazine as measured by ACPRTimepoint: ACPR at Day 28 SECONDARY OUTCOME: Parasite clearance time (PCT).Timepoint: Baseline to Parasite clearance time. To evaluate fever clearance.Timepoint: Baseline to EOS To evaluate the efficacy of Zintrodiazine as measured by ACPRTimepoint: on Day 14 To evaluate the safety and tolerability of Zintrodiazine in Indian adults with uncomplicated P. viva Xmalaria.Timepoint: at Days 14 and 28. INCLUSION CRITERIA: 1)Ability to swallow oral medication. 2)Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and that all questions by the participant have been sufficiently answered. 3)Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4)Microscopic confirmation of P. viva Xby thin and thick blood smear with parasite density of greater than 250 parasites per microL 5)Axillary temperature greater than equal to 37.5 C or history of fever within 24 h of screening. 6)Age greater than 18 years and body weight greater than 45 kg 7)Hemoglobin greater than 9 gram per dL
Epistemonikos ID: bf4d2a070c981575eb04062ad11a72bb21ae8bb2
First added on: Aug 08, 2026