drugset / Trial / NCT06121934
Efficacy and Safety of Carica Papaya in Dengue Fever: A Randomised Clinical Trial
Phase 3
Completed
250 enrolled
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Institute of Technology Transfer and Innovation (ITTI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2023-10-01
- Primary completion
- 2023-12-20
- Completion
- 2023-12-27
Publications
- Background Ahmad N, Fazal H, Ayaz M, Abbasi BH, Mohammad I, Fazal L. Dengue fever treatment with Carica papaya leaves extracts. Asian Pac J Trop Biomed. 2011 Aug;1(4):330-3. doi: 10.1016/S2221-1691(11)60055-5.
- Background Subenthiran S, Choon TC, Cheong KC, Thayan R, Teck MB, Muniandy PK, Afzan A, Abdullah NR, Ismail Z. Carica papaya Leaves Juice Significantly Accelerates the Rate of Increase in Platelet Count among Patients with Dengue Fever and Dengue Haemorrhagic Fever. Evid Based Complement Alternat Med. 2013;2013:616737. doi: 10.1155/2013/616737. Epub 2013 Apr 11.
- Background Kasture PN, Nagabhushan KH, Kumar A. A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever. J Assoc Physicians India. 2016 Jun;64(6):15-20.
- Background Sarker MMR, Khan F, Mohamed IN. Dengue Fever: Therapeutic Potential of Carica papaya L. Leaves. Front Pharmacol. 2021 Apr 26;12:610912. doi: 10.3389/fphar.2021.610912. eCollection 2021.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carica Papaya Leaf Extract | Unknown | 1000 mg | Oral |