| CTRI Number |
CTRI/2017/07/009139 [Registered on: 27/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Is Papaya leaf extract useful in treating Dengue patients? |
|
Scientific Title of Study
|
Effectiveness of Carica Papaya leaf extract in increasing the platelet count in cases of dengue fever with thrombocytopenia†– A double blind placebo randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gift Norman |
| Designation |
HOD Community Health Division |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community Health Division Bangalore Baptist Hospital Bellary road Hebbal
Bangalore Baptist Hospital Bellary road Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9591761106 |
| Fax |
|
| Email |
normangift@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Carolin Elizabeth George |
| Designation |
Consulant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community Health Division
Bangalore Baptist Hospital
Bellary road Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9972156838 |
| Fax |
|
| Email |
carolinelizabethj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Carolin Elizabeth George |
| Designation |
Consulant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community Health Division
Bangalore Baptist Hospital
Bellary road Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9972156838 |
| Fax |
|
| Email |
carolinelizabethj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore baptist hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital Bellary road Hebbal |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gift Norman |
Bangalore Baptist Hospital |
Department of Medicine Bangalore Baptist Hospital Bellary road Hebbal
Bangalore
KARNATAKA |
9591761106
normangift@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with dengue fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C.papaya capsule (Caripil)
|
Caripil 1100 mg three times daily for 5 days, along with the standard regimen. |
| Comparator Agent |
Placebo |
The other group will receive placebo three times daily for 5 days, along with the standard regimen |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
• 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean platelet count |
Day 1, 2, 3,4 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Morbidity profile
WBC count
RBC count |
Days 1, 2, 3, 4 and 5 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|