Home » Trials » SLCTR/2017/034
Effect of papaya (Carica papaya) leaf extract on plasma leakage and platelet count in dengue fever: a randomized controlled trial
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SLCTR Registration Number
SLCTR/2017/034
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of papaya (Carica papaya) leaf extract on plasma leakage and platelet count in dengue fever: a randomized controlled trial
Public Title of Trial
Study on the effects of papaya leaf extract on plasma leakage and platelet count in dengue fever
Disease or Health Condition(s) Studied
Dengue fever
Scientific Acronym
None
Public Acronym
None
Brief title
Papaya leaf extract in dengue fever
Universal Trial Number
U1111-1206-2748
Any other number(s) assigned to the trial and issuing authority
15.08.2017: 4.2 (ERC: Ruhuna)
What is the research question being addressed?
What is the effect of papaya leaf extract(PLE), given during the pre-critical phase, on the plasma leak and platelet count in patients with dengue fever?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
The study will be carried out at Teaching Hospital, Karapitiya
Participants meting the inclusion/exclusion criteria will be randomized into the study arms using a computer generated random number table
Intervention product: Carica papaya leaf extract (PLE) prepared as described by Hettige, 2015.
The intervention arm will receive PLE 25ml (extracted from 50g of fresh papaya leaves), orally, twice daily for 5 days. This will be in addition to the standard management of dengue fever according to the Sri Lankan Guidelines on DF published by the Ministry of Health in 2012.
The control group will receive standard management only.
Inclusion criteria
Male and female patients aged between 14-70 years
Dengue fever confirmed by positive dengue antigen or specific IGM
Platelet count <150,000/microlitre
Exclusion criteria
Primary outcome(s)
|
1.
The occurrence and severity of plasma leakage Occurrence of plasma leak will be determined ultrasonically. The severity of leak will be determined by the requirement of crystalloid and colloid boluses and blood transfusions. |
[ Daily until complete recovery |
Secondary outcome(s)
|
1.
Severity of thrombocytopenia (absolute platelet count) |
[ Daily until complete recovery |
|
2.
Derangement of liver transaminases (absolute serum AST and ALT) |
[ Daily until complete recovery |
|
3.
Duration of hospital stay |
[] |
Target number/sample size
120 in each arm (240 total)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-10-09
Anticipated end date
2017-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-08-22
Approval number
15.08.2017: 4.2
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Sarath Lekamwasam
Professor of Medicine
Population Health Research Center
Department of Medicine,
Faculty of Medicine,
Karapitiya, Galle
Sri Lanka
tel: 912234730
mob: 0777275360
slekamwasam@gmail.com
Contact Person for Public Queries
Prof. Sarath Lekamwasam
Professor of Medicine
Population Health Research Center
Department of Medicine,
Faculty of Medicine,
Karapitiya, Galle
Sri Lanka
tel: 912234730
mob: 0777275360
slekamwasam@gmail.com
Primary study sponsor/organization
Dr. RWK Kodokara Arachchi
Consultant Physician
Teaching Hospital
Karapitiya, Galle, Sri Lanka
Mob: 0773082357
rwkkody@gmail.com
Secondary study sponsor (If any)
Dr Mrs JDVC Lekamwasam
Consultant Physician
Teaching Hospital
Karapitiya, Galle, Sri Lanka
Mob: 0777552350
vajiralekamwasam@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
