Efficacy and Safety of Carica Papaya in Dengue Fever: A Randomised Clinical Trial

BSMMU/2023/12097

This will be a placebo-controlled, multicenter-randomized prospective study of CPLE (Carica papaya leaf extract) tabs in dengue patients (WHO-Group A, B). The study will enroll 300 eligible dengue cases into two arms: one arm receiving CPLE 1000mg t.i.d for 5 days and the other group receiving a placebo. The main question to ask is whether CPLE reduces severe disease progression and increases platelet counts in dengue patients. The participant will be asked to take orally available CPLE capsules at a dose of 1000 mg (2 capsules, 500mg each) or identical placebo three times a day for 5 days

2023-10-01

2023-12-20

2023-12-27

Completed

Early phase I

250

Inclusion Criteria: * Patients who are confirmed dengue fever by NS1 dengue Ag or anti dengue Ab IgM positive Exclusion Criteria: * Children (\<18 years) * Currently pregnant or lactating * Patients on steroids, any immunosuppressant * Patients who received platelet transfusion during the same admission * Patient with other known causes of thrombocytopenia, including leukemia, ITP * Patients with alanine aminotransferase (ALT) levels \>150 U/L * Patient with serum creatine \>1.4 mg/dl * S. creatine kinase (CK) \>1000 U/L

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms are being used in this study, One arm contains active drug and other contains placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The recruiter, caregiver, randomizer, and investigator all are blinded, except for the manufacturer', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ACTUAL'}}

2023-12-29