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SLCTR Registration Number
SLCTR/2013/005
Date of Registration
The date of last modification
Jun 03, 2013
View original TRDS
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
None
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
Study 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.
|
[ 1 -7 : at recruitment and daily until discharge 8.: before ingestion of first dose and after completing 3 days of treatment ] |
|
2.
The platelet count |
[ At recruitment and daily until discharge ] |
|
3.
Haematocrit |
[ At recruitment and daily until discharge ] |
|
4.
The prothrombin time (PT) |
[ At recruitment and daily until discharge ] |
|
5.
Alanine aminotransferase (ALT) |
[ At recruitment and daily until discharge ] |
|
6.
Presence of pleural effusion |
[ At recruitment and daily until discharge ] |
|
7.
Serum cholesterol |
[ At recruitment and daily until discharge ] |
|
8.
CD 4 counts |
[ 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
2013-09-30
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
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
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
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
