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Effect of papaya (Carica papaya) leaf extract on plasma leakage and platelet count in dengue fever: a randomized controlled trial -

SLCTR Registration Number

SLCTR/2017/034


Date of Registration

07 Oct 2017

The date of last modification

Oct 07, 2017



Application Summary


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 of Health Condition(s) Studied

Dengue fever


Scientific Acronym

None


Public Acronym

None


Brief title

Papaya leaf extract in dengue fever


Universal Trail Number

None


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

15.08.2017: 4.2 (ERC: Ruhuna)


Trial Details


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


Assignment

Parallel


Purpose

Treatment


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

  1. Male and female patients aged between 14-70 years

  2. Dengue fever confirmed by positive dengue antigen or specific IGM

  3. Platelet count <150,000/microlitre


Exclusion criteria

  1. Plasma leak determined by ultrasonography
  2. Pregnant or lactating
  3. Decompensated cardiac failure as determined by clinical features
  4. Ongoing renal or hepatic disease as determined by clinical features and lab investigations
  5. BMI >35kg/m2
  6. Known allergy to papaya
  7. Previous history of bleeding or platelet disorders
  8. Active peptic ulcer disease
  9. Concurrent anticoagulant therapy


Primary outcome(s)

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.


Primary outcome(s) - Time of assessment(s)

Daily until complete recovery
Complete recovery will be defined as defervescence and rise of platelet count >75,000/microlitre


Secondary outcome

  1. Severity of thrombocytopenia (absolute platelet count)
  2. Derangement of liver transaminases (absolute serum AST and ALT)
  3. Duration of hospital stay

Secondary outcome(s) - Time of assessment(s)

  1. Severity of thrombocytopenia (absolute platelet count)
  2. Derangement of liver transaminases (absolute serum AST and ALT)
  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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Ruhuna on 22nd Aug 2017 (Ref No. 15.08.2017: 4.2)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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