Effect of Carica papaya leaf extract on Dengue Feve

• Register: SLCTR
• Last refreshed on: 1 April 2024
• Main ID: SLCTR/2013/005
• Date of registration: 2013-01-21
• Prospective Registration: Yes
• Primary sponsor: None
• Public title: Effect of Carica papaya leaf extract on Dengue Feve
• Scientific title: Controlled trial on effect of Carica papaya leaf extract on patients with Dengue Fever
• Date of first enrolment: 2013-04-01
• Target sample size: 41 patients for treatment group and 41 patients for control group
• Recruitment status: Complete: follow up complete
• URL: https://slctr.lk/trials/slctr-2013-005
• Study type: Interventional
• Study design: Randomized controlled trial
• Phase: Not Available

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. Sanath Hettige
• Affiliation: Consultant Family physician

• Name: Dr. Lagath Udara Wanigabadu ,

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Dengue fever

Intervention(s)

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.

Primary Outcome(s)

White blood cell count (WBC) / Differential counts
[At recruitment and daily until discharge ]
The platelet count
[At recruitment and daily until discharge ]
Haematocrit [At recruitment and daily until discharge ]
The prothrombin time (PT) [At recruitment and daily until discharge ]
Alanine aminotransferase (ALT) [At recruitment and daily until discharge ]
Presence of pleural effusion [At recruitment and daily until discharge ]
Serum cholesterol [At recruitment and daily until discharge ]
CD 4 counts [Before ingestion of first dose and after completing 3 days of treatment]

Secondary Outcome(s)

Duration of hospital stay [At discharge]

Source(s) of Monetary Support

None

Ethics review

Status: Approved
Approval date: 30/08/2012
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura

[phone] (Extension: 4075)

[e-mail]