To Assess the Efficacy of Carica Papaya Leaf Extract in Improving Platelet Counts Among Pediatric Patients With Dengue-associated Thrombocytopenia

NCT07172100 | Enrolling By Invitation Phase 2

• 1 other identifier: 6600223GMPED
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether Carica papaya leaf extract (CPLE) can improve platelet counts in children aged 2 to 12 years diagnosed with dengue fever and thrombocytopenia. The main questions it aims to answer are: Does Carica papaya leaf extract significantly increase platelet counts compared to standard supportive therapy alone? Does the use of Carica papaya leaf extract reduce the need for platelet transfusion or PICU admission? Researchers will compare the group receiving CPLE plus standard therapy to the group receiving standard therapy alone to see if CPLE leads to improved platelet recovery and better clinical outcomes. Participants will: Be randomly assigned to receive either standard care or standard care plus Carica papaya leaf extract syrup (10 mL orally, three times daily for 3 days) Undergo blood testing on Day 1 and Day 3 to assess platelet count, hemoglobin, WBC, and packed cell volume Be monitored for clinical outcomes including need for transfusion and admission to the Pediatric Intensive Care Unit (PICU)

Conditions

Dengue Fever; Papaya Leaf Extract; Pediatric Patients

Keywords

effect of papaya leaf extract; dengue fever; platelet count

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Count from Day 1 to Day 3

  To evaluate the effectiveness of Carica papaya leaf extract in increasing platelet count in pediatric patients with dengue-associated thrombocytopenia

  Baseline (Day 1) and Day 3

Study Arms (2)

Carica Papaya Leaf Extract Group

EXPERIMENTAL

Participants in this arm will receive oral Carica papaya leaf extract syrup (10 mL containing 1000 mg of extract), administered three times daily for 3 days, along with standard supportive care for dengue fever. Standard therapy includes hydration, antipyretics, and monitoring per hospital protocol.

Drug: Carica Papaya Leaf Extract Group

Standard Therapy Group

ACTIVE COMPARATOR

Participants in this arm will receive standard supportive treatment for dengue fever, including antipyretics, fluids, and monitoring as per institutional protocol. No Carica papaya leaf extract will be administered.

Other: standard treatment

Interventions

Carica Papaya Leaf Extract Group DRUG

Carica papaya leaf extract syrup will be administered orally at a dose of 10 mL three times daily (TID) for a total of 3 days. Each 10 mL dose contains 1000 mg of papaya leaf extract. This intervention will be given in addition to standard supportive therapy for dengue fever

Carica Papaya Leaf Extract Group

standard treatment OTHER

patients in this group will receive only the standard treatment for dengue fever

Standard Therapy Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with dengue fever
• Patients from age 2 till 2 years of age

You may not qualify if:

• Patients hypersensitive to papaya leaf extract
• Patients with bleeding disorder

Sponsors & Collaborators

• Ziauddin Hospital: lead

Study Sites (1)

Guzel Maxood

Karachi, Pakistan

Location

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)