| CTRI Number |
CTRI/2014/10/005120 [Registered on: 20/10/2014] Trial Registered Prospectively |
| Last Modified On: |
17/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the mechanism of action of papaya leaf extract in dengue patients |
|
Scientific Title of Study
|
EFFECT OF CARICA PAPAYA LEAF EXTRACT ON PLATELET AGGREGATION, MEMBRANE FLUIDITY AND P-SELECTIN EXPRESSION IN DENGUE INFECTION: A 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 PRABHAT |
| Designation |
junior resident |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Department of Biochemistry,
JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9984150799 |
| Fax |
|
| Email |
drprabhat12811281@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R SOUNDRAVALLY |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Associate Professor,
Department of Biochemistry,
JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
0413-2272066 |
| Fax |
|
| Email |
soundy27@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R SOUNDRAVALLY |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Associate Professor,
Department of Biochemistry,
JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
0413-2272066 |
| Fax |
|
| Email |
soundy27@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| intramural fund from Jawaharlal Institute of Post graduate
Medical Education and Research (JIPMER)
Dhanvantri Nagar,Puducherry605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post graduate Medical Education and Research JIPMER |
| Address |
Dhanvantri Nagar,Puducherry605006
|
| Type of Sponsor |
Government medical college |
|
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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 Soundravally Rajendiran |
Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER). |
Department of Biochemistry,ACADEMIC BLOCK,2ND FLOOR
Jawaharlal Institute of Post graduate
Medical Education and Research (JIPMER)
Dhanvantri Nagar,Puducherry ,PIN 605006;
Pondicherry
PONDICHERRY |
0413-2272066
soundy27@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry,institute ethics committee(human studies) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
non-severe dengue patients., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dengue patients on standard treatment |
Dengue patients are conventionally managed by intravenous fluids and platelet transfusion, as per severity of case. |
| Intervention |
Dengue patients on standard treatment and Carica papaya leaf extract capsule [PAPAYUR (Papaya leaf extract 10:1,600mg capsule] supplied by BIOEXTRACT.600 mg capsule two times a day oral for 12 days. |
Carica papaya leaf extract capsule [PAPAYUR (Papaya leaf extract 10:1,600mg capsule) supplied by, BIOEXTRACT, An ISO & Kosher Certified company. Registered in India.]
company license no.112123140000250.ISO Certificate no.140102019112
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
 Dengue Fever Subjects 18-60 yrs positive for dengue NS1 antigen or anti IgM/IgG dengue antibodies or virus by Reverse Transcriptase PCR.
|
|
| ExclusionCriteria |
| Details |
 Dengue fever group C and those with bleeding manifestations other than petechiae/purpura
 Pregnant or lactating women.
 Known case with hepatic and renal diseases.
 Patients with inherited platelet disorders
 Patients on medications which interfere with platelet function (NSAIDs) will be excluded from the study.
 History of allergic reactions to papaya.
 Patients with more than 2 episodes of vomiting in the past 24 hours.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| supplementation of papaya leaf extract to dengue patients increases platelet aggregation,decreases membrane fluidity and p-selectin expression |
1st day, 3rd day and 7th day of start of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in platelet count and hematocrit value. |
0,3rd and 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
24/10/2014 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
40 patients with dengue infection(Group
I) and 20 controls(Group II) will be
studied and blood samples will be collected to estimate Platelet aggregation and
its membrane fluidity and P-Selectin levels. Group I will be further divided
into two groups as Group Ia and Group Ib. Group Ia will get supportive
treatment and Carica papaya leaf extract . Group Ib will get Supportive
treatment only. In case of Group I (Dengue) and Group II
(Healthy subjects) five milliliter of blood sample will be collected. First sample will be
collected for both Group I (Dengue) and Group II (Healthy subjects), within
24-48 hrs of admission. 2nd and 3rd sample will be
collected for Group I (Dengue) subjects only. 2nd sample will be
collected at 3rd day of admission and third sample at 7rd
day or at the time of discharge whichever is earlier. Blood samples will be
tested for P-Selectin,Platelet aggregation and Platelet membrane fluidity.Platelet
aggregation will be expressed in percentage (%). Platelet membrane fluidity will be expressed in florescence units. Mean with standard deviation will be calculated for
expression of CD markers on platelets and ANOVA with Bonferroni test will be
used for comparing means between the groups. A p value of <0.05 will be
considered as statistically significant difference between the groups.
Appropriate parametric ( Paired ’t’
test) and non parametric (mann-whitney ’U’ test) will be used to compare the
continuous variables between the groups.The
study protocol will conform to standard ethical guidelines. |