| CTRI Number |
CTRI/2019/04/018435 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
03/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Carica Papaya Leaf
extract capsule on platelet counts in Dengue fever |
|
Scientific Title of Study
|
Profile of Dengue Fever and effect of carica papaya leaf extract capsule on platelet counts and clinical bleeding |
| Trial Acronym |
CARDEN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh babu |
| Designation |
Post graduate resident , |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
2,3 , 2nd cross stree , 7th main road extension , new colony , chromepet , chennai - 600 044
Department of general medicine , Room no : 208 , annexue mens hostel , Pondicherry institute of medical sciences
Viluppuram
TAMIL NADU
600 044
India |
| Phone |
9790740295 |
| Fax |
|
| Email |
dineshbb1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhagar |
| Designation |
post graduate resident |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Department of general medicine , Pondicherry institute of medical sciences
Department of general medicine , Pondicherry institute of medical sciences
Pondicherry
PONDICHERRY
605014
India |
| Phone |
09944667893 |
| Fax |
|
| Email |
drsudhagar7893@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh babu |
| Designation |
Post graduate resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
2,3 , 2nd cross stree , 7th main road extension , new colony , chromepet , chennai - 600 044
Viluppuram
TAMIL NADU
600 044
India |
| Phone |
9790740295 |
| Fax |
|
| Email |
dineshbb1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Dinesh Babu
Post graduate resident
Room no : 208 , annexue mens hostel , Pondicherry institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Dinesh babu |
| Address |
2,3 , 2nd cross street , 7th main road extn , new colony , chromepet , Chennai 600 044 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DINESH BABU |
Pondicherry institute of medical sciences |
Room no : 208 , annexue mens hostel, Pondicherry institute of medical sciences, kalapet , kanagachettikulam , Pondicherry - 605014
Pondicherry
PONDICHERRY |
9790740295
dineshbb1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carica papaya leaf extract capsule |
Carica papaya leaf extract capsule given 1100 mg thrice daily orally for 5 days |
| Comparator Agent |
PLACEBO |
Multivitamin capsule |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged more than 18 yrsadmitted with fever and dengue Ns1Ag (OR) IgM positive |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic liver disease
2. Patients with dengue co-infectionlike malaria , typhoid , scrub typhus.
3. Patient with platelet disorders (eg:Immune thrombocytopenic purpura)
4. Pregnant women with dengue fever.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To describe the clinical profile of dengue fever in adult patients admitted in PIMS
2. To determine the effect of carica papaya leaf extract capsuleon platelet counts in adult patients of dengue fever admitted in PIMS
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether carica papaya leaf extract capsule reduce hemorrhagic manifestations |
10 months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2019 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
As many physicians in india use carica papaya leaf extract capsule for improvement in platelet counts in dengue fever , but there are very few studies proving their benefit. Hence this study was done in my institution to study the effect of the drug. Commercially available carica papaya leaf capsule is given as 1100 mg thrice daily for 5 days and hypothesised that it will increase or prevent fall in platelet counts in dengue fever and reduce hemorrhagic manifestations |