Home » Trials » SLCTR/2013/005

Controlled trial on effect of Carica papaya leaf extract on patients with Dengue Fever -

SLCTR Registration Number


Date of Registration

21 Jan 2013

The date of last modification

Nov 21, 2017

View original TRDS

Trial Status

Application Summary

Scientific Title of Trial

Controlled trial on effect of Carica papaya leaf extract on patients with Dengue Fever

Public Title of Trial

Effect of Carica papaya leaf extract on Dengue Feve

Disease or Health Condition(s) Studied

Dengue fever

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

673/12 (Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayewardenepura)

Trial Details

What is the research question being addressed?

What is the effect of oral Carica papaya extract on the haematological and biochemical profiles and hospital stay of dengue patients?

Type of study


Study design


Randomized controlled trial


Masking not used


Standard therapy






Intervention(s) planned

Consenting patients will be randomized into treatment and control groups. The treatment group will be given Carica papaya leaf extract. The extract will be prepared by crushing fresh mature Papaya leaves in a wooden mortar-pestle and the juice extracted by a juice extractor.20ml of the extract will be administered 8 hourly until the patient is discharged. All patients in the treatment group will be closely observed for one hour following treatment for any possible side effects and of any unusual medical signs or symptoms. The control group will not be given papaya extract. The standard treatment given to all dengue patients will be continued throughout without interruption for both treatment and control groups.

Inclusion criteria

Male and female patients admitted to the university medical unit at Colombo South Teaching Hospital fulfilling ALL the following criteria will be included in this study. (1) >18 and <60 years of age (2) Acute onset of fever (3) Platelet count <150,000 per cu.mm and / or Hct elevated by 5% and / or white cell count <5000/cu.mm. (4) Dengue IgM positive after 7 days of illness

Exclusion criteria

(1) History of allergy to papaya (2)Pregnancy (3)Patients who have already taken papaya juice extracts before admitting to hospital (4) Patients with previously diagnosed abnormal clotting profile as per past history and medical records (5) Patients suffering from any other illnesses which will influence the course of dengue fever. (6) Patients suffering from any other illnesses or on drugs which will influence the bone marrow function or haemopoitic system. (7) Dengue patients who are being treated with blood products. (8) Patients with severe hemorrhagic dengue (9) Dengue IgM negative after 7 days of the illness

Primary outcome(s)

    1. White blood cell count (WBC) / Differential counts
    2. The platelet count
    3. Haematocrit
    4. The prothrombin time (PT)
    5. Alanine aminotransferase (ALT)
    6. Presence of pleural effusion
    7. Serum cholesterol
    8. CD 4 counts

    1 -7 : at recruitment and daily until discharge 8.: before ingestion of first dose and after completing 3 days of treatment


Secondary outcome(s)

  1. Duration of hospital stay


    At discharge


Target number/sample size

41 patients for treatment group and 41 patients for control group

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source


State of Ethics Review Approval


Date of Approval

Approval number

Details of Ethics Review Committee

Institutional Address:

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Sanath Hettige
Consultant Family physician
92, Wattegedara Road, Maharagama


Contact Person for Public Queries

Dr. Lagath Udara Wanigabadu ,

45/12, Bishop Terrace, Laxapathiya, Moratuwa



Primary study sponsor/organization


Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Protocol URL

Results summary available

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results