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

• Status: Completed
• Trial end date: 2023-12-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Collaborator: Institute of Technology Transfer and Innovation (ITTI)

Criteria

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