Home » Trials » SLCTR/2013/005


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

SLCTR Registration Number

SLCTR/2013/005


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

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Treatment


Phase


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

2013-04-01


Anticipated end date

2013-04-01


Date of first enrollment


Date of study completion


Recruitment status

Complete


Funding source

None



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Sanath Hettige
Consultant Family physician
92, Wattegedara Road, Maharagama
0112851517
0772283730

hettiges@sltnet.lk

Contact Person for Public Queries

Dr. Lagath Udara Wanigabadu ,

45/12, Bishop Terrace, Laxapathiya, Moratuwa

0772264232

lagathurc@yahoo.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





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