| CTRI Number |
CTRI/2018/08/015526 [Registered on: 29/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial for prevent platelet fall in dengue infection |
|
Scientific Title of Study
|
A Multi-centric, Double blind, Prospective, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract (CARIMAX), as empirical therapy for prevent Thrombocytopenia associated with Dengue Fever |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNagabhushan KH |
| Designation |
Director - Innovation and Implementation |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
7026242388 |
| Fax |
|
| Email |
nagabhushandr@katraphyto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNagabhushan KH |
| Designation |
Director - Innovation and Implementation |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
7026242388 |
| Fax |
|
| Email |
nagabhushandr@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNagabhushan KH |
| Designation |
Director - Innovation and Implementation |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
7026242388 |
| Fax |
|
| Email |
nagabhushandr@katraphyto.com |
|
|
Source of Monetary or Material Support
|
| Katra Phytochem (India) Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Katra Phytochem Pvt ltd |
| Address |
Plant No. 7, A-1, Attibele Industrial Area,
Anekal Taluk, Bangalore District - 562107
Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrS Poorna prasad |
Shettys Hospital |
Plot No. 11 & 12, 12th F Main Road, Kaveri Nagar, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
9741941064
drpoorna.prasad01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shettys hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dengue patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARIMAX (Papaya leaf extract 1100mg) |
three times daily (TID)
Total duration : 5 days
Route: by orally
|
| Comparator Agent |
Placebo |
Three times daily (TID) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were confirmed to have DF or DHF grade I and II,
2. Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial,
3. Male and female patients above 18 years and below 60 years old,
4. Patients with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165 U/L),
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women,
2. Patients with Dengue hemorrhagic fever grade III and IV,
3. Patients with platelet count less than 20000/microlitre
4. Patients with thrombocytopenia presenting with active bleeding
5. Patients who have received blood or blood products transfusion during the current illness or during past one week,
6. Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia or bleeding diathesis
7. Patients who developed Hepatitis with a serum ALT level 3 times higher than the upper limit of the normal range (>165 U/L).
8. Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females)
9. Participation in another trial with another investigational drug within 1 month prior to informed consent.
10. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study
11. Hypersensitivity to any of the components of the investigational formulation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in the platelet counts from the baseline levels to the end of therapy |
Day 1, Day 2,Day 3,,Day 4 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the RBC levels from the baseline levels till the end of therapy
Change in WBC levels from the baseline levels till the end of therapy
Change in the Haematocrit levels from the baseline levels to the end of therapy
Comparison of incidence and rate of adverse events occurred between the two arms to evaluate the safety and tolerability
|
Day 1, Day 2,Day 3,,Day 4 and Day 5
|
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/08/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East
Asian countries on the effectiveness of carica papayaleaf extract on
increasing the platelet counts in patients with thrombocytopenia associated
with Dengue.
This trial is designed as Multi-centric, double blind, placebo controlled,
Randomized, Prospective study in patients aged 18 years and above and
having thrombocytopenia associated with dengue fever |