Is Papaya leaf extract useful in treating Dengue patients?

Phase 2/3

Recruiting

• Conditions: Patients with dengue fever

• Registration Number: CTRI/2017/07/009139
• Lead Sponsor: Bangalore Baptist Hospital

Brief Summary

**Title  - “Effectiveness of Carica Papaya leaf extract in increasing the platelet count in cases of dengue fever with thrombocytopenia†– A double blind randomized placebo controlled trial**

**Introduction -**Dengue is a tropical infection that is highly prevalent in rainy season in tropical countries like India. This mosquito borne viral infection is known to cause thrombocytopenia which is associated with higher morbidity and mortality.Currently there are no specific antiviral agents effective for Dengue infection. In the recent years, there are few reports showing clinical usefulness of papaya leaf extract for dengue.

**Objectives**1.      To determine the effectiveness of papaya leaf extract in increasing platelet count in patients with Dengue fever

2.      To compare the morbidity profile of patients with Dengue fever who were given papaya leaf extract and  the controls

Primary outcome variable: mean platelet count

**Method**  - Double blind randomized placebo controlled trial.A total of 100 subjects (n=100) diagnosed as dengue cases by NS 1 Ag &Ab (IgG/IgM) to be enrolled in this study. Inclusion and exclusion criteria will be followed. Informed consent shall be taken. The patients will be randomized to be in either of the groups. One group will receive Caripil 1100 mg three times daily for 5 days. The other group will receive placebo three times daily for 5 days. All the patients will be advised not to take any formulation containing papaya extract.

Blood samples will be checked twice a day for platelets and once a day for hematocrit in the clinical hospital laboratory during hospitalization period. During the course of study, if the platelet count falls below the critical value of less than 10,000 or if the patient presents with bleeding manifestation requiring platelet transfusion shall be treated accordingly and will be excluded from the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-03
• Last Update Posted: 2017-10-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inclusion criteria a.
• Age 15-70 years and b.
• Dengue Ag/Ab OR both Ag, Ab positive c.
• Inpatients d.
• Platelet count less than 1,00,000 and e.
• Patients willing to participate in study and given informed consent.

Exclusion Criteria

• •Pregnant or lactating women •Patients with Dengue hemorrhagic fever grade III and IV, •Patients with platelet count less than 10000/micro liter •Patients with thrombocytopenia presenting with active bleeding •Patients who have received blood or blood products transfusion during the current illness or during past one week, •Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia or bleeding diathesis •Patients with history of papaya leaf extract consumption prior to admission.
• •Participation in another trial with another investigational drug within 1 month prior to informed consent.
• •The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean platelet count	Day 1, 2, 3,4 and 5

Secondary Outcome Measures

Name	Time	Method
Morbidity profile	WBC count

Trial Locations

Locations (1)

Bangalore Baptist Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Baptist Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Gift Norman

Principal investigator

9591761106

normangift@gmail.com