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

NCT06945679 | Completed Phase 1 DMC

• 1 other identifier: BSMMU/2024/3129
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rise in platelet count

  The treatment and placebo groups will compare the peak platelet count

  5 days

Secondary Outcomes (1)

• Return of hematocrit levels towards baseline

  5 days

Other Outcomes (1)

• Bleeding Manifestations

  six days

Study Arms (2)

CPLE group

ACTIVE COMPARATOR

After confirming the diagnosis of Dengue fever,the potential benefits and risks of the use of CPLE in capsule form will be explained to the patients.Patients will be properly explained about purpose and procedure of the study.After taking informed written consent, 168 patients with dengue fever will be finally enrolled in the study.Then total 168 patients will be randomized into 2 groups by using website www.randomization.com. 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: CPLE

Placebo

PLACEBO COMPARATOR

he patients will be assigned to one of the two treatment arms: 1. Active drug: CPLE 500mg 2 capsule t.i.d for 5 days 2. 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). 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.

Drug: Placebo

Interventions

CPLE DRUG

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.

CPLE group

Placebo DRUG

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.

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 positive NS1 dengue Antigen and/ Dengue IgM antibody.
• Day of illness ≤ 5 days

You may not qualify if:

• Children (\<18 years)
• Patients already getting Papaya
• Currently pregnant or lactating
• Patients on steroids or any immunosuppressant
• Patients who received platelet transfusion during the same admission
• Patient with known causes of thrombocytopenia
• Patients with alanine aminotransferase (ALT) levels \>150 U/L
• Patient with serum creatinine \>1.4 mg/dl

Sponsors & Collaborators

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

Study Sites (1)

Prof Shohael Mahmud Arafat

Dhaka, Dhaka Division, 1000, Bangladesh

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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 28, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

BA (1)