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Effects of Carica Papaya Leaf Extract (CPLE) in the Outcome of Hospitalized Dengue Patients

NCT06945679 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-04-25

No results posted yet for this study

Summary

Its a double-blind placebo controlled multicenter study involving confirmed dengue patients who are hospitalized.168 Patients will be enrolled according to specific inclusion \& exclusion criteria and they will be divided into two equal arms..After taking informed written consent patients will be provided with either CPLE 500 mg 2 capsule 3 times daily for 5 days or placebo and they will be followed up upto discharge from hospital or ICU transfer or death.

We want to see the effects of CPLE in the outcome of hospitalized dengue patients in comparison to placebo group.

Participants will be asked to take oral CPLE or placebo 500 mg 2 capsules 3 times daily for 5 days.

Conditions

  • Dengue Fever

Interventions

DRUG

CPLE

It will be a double-blind study,CPLE and Placebo will be marked as either Group A or Group B.Half of the patients will receive Group A and other half will receive Group B drug along with standard treatment according to national guideline,Each participant will receive either CPLE or Placebo,500 mg 2 capsules three times daily for 5 days and will be followed up daily upto study day 5.

DRUG

Placebo

The patients will be assigned to 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). On receipt, the medications will be stored in a secure area at room temperature. Enrolled patients will receive CPLE or placebo for 5 days. Clinical data will be captured on structured case report forms.

Sponsors & Collaborators

  • Institute of Technology Transfer & Innovation (ITTI)

    collaborator UNKNOWN

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-02-20
Completion
2025-02-28

Countries

  • Bangladesh

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945679 on ClinicalTrials.gov