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

NCT06121934 | Completed Phase 3 DMC

• 1 other identifier: BSMMU/2023/12097
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dengue

Keywords

Dengue fever; severity reduction; carica papaya; CPLE; RCT

Outcome Measures

Primary Outcomes (2)

• Rise in platelet counts

  The treatment and placebo groups will compare the peak platelet count

  Within five days

• Return of hematocrit levels towards baseline

  The treatment and placebo groups will compare the normalization of hematocrit value

  Within five days

Secondary Outcomes (2)

• Bleeding Manifestations

  Within six days

• Duration of hospital stay

  Within six days

Study Arms (2)

Carica Papaya Leaf Extract

EXPERIMENTAL

The study patients will be followed for clinical and laboratory endpoints in the hospital until study day 5 (or daily as outpatients from discharge to day 5) and reviewed at an outpatient visit at week 2 after discharge. The patients will be assigned to one of the two treatment arms after randomization: 1\) Active drug: Carica papaya leaf extract (CPLE) 500mg 2 capsule t.i.d for 5 days The oral capsule of CPLE and placebo will be provided by the Institute of Technology Transfer and Innovation (ITTI), an institute in Bangladesh Council of Scientific and Industrial Research (BCSIR), with appropriate masking for a double-blind study. On receipt, the medications will be stored in a secure area by the manufacturer's recommendation.

Drug: Carica Papaya Leaf Extract

Placebo

PLACEBO COMPARATOR

The study patients will be followed for clinical and laboratory endpoints in the hospital until study day 5 (or daily as outpatients from discharge to day 5) and reviewed at an outpatient visit at week 2 after discharge. The patients will be assigned to standard treatment with placebo after randomization: Placebo: visually matched placebo 2 capsule t.i.d for 5 days The oral capsule of CPLE and placebo will be provided by the Institute of Technology Transfer and Innovation (ITTI), an institute in Bangladesh Council of Scientific and Industrial Research (BCSIR), with appropriate masking for a double-blind study. On receipt, the medications will be stored in a secure area by the manufacturer's recommendation.

Drug: Placebo

Interventions

Carica Papaya Leaf Extract DRUG

Active drug: CPLE 500mg 2 capsule t.i.d for 5 dayseive CPLE or placebo once daily for 5 days.

Carica Papaya Leaf Extract

Placebo DRUG

Placebo: visually matched placebo 2 capsule t.i.d for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are confirmed dengue fever by NS1 dengue Ag or anti dengue Ab IgM positive

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Institute of Technology Transfer and Innovation (ITTI): collaborator

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

Location

Related Publications (4)

• 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.

  PMID: 23569787 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.

  PMID: 23662145 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.

  PMID: 27739262 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.

  PMID: 33981215 BACKGROUND

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The recruiter, caregiver, randomizer, and investigator all are blinded, except for the manufacturer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two arms are being used in this study, One arm contains active drug and other contains placebo

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 8, 2023
• Study Start: October 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 27, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after completion of study

Locations

BA (1)