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CTRI Number  CTRI/2017/08/009579 [Registered on: 31/08/2017] Trial Registered Retrospectively
Last Modified On: 23/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Caripill drug on severely low platelet counts in patients with dengue disease 
Scientific Title of Study   A prospective study to evaluate the safety and efficacy of Carica papaya leaf extract (Oral Caripill) in the treatment of severe thrombocytopenia (s30,000/µl) in dengue  
Trial Acronym  AIMSCARI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya P Menon 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences 
Address  Dept of General Medicine Amrita Institute of Medical Sciences and Research Center, AIMS Ponekkara, Kochi.

Ernakulam
KERALA
682041
India 
Phone  04842851838  
Fax  04842802020  
Email  vidyamenon@aims.amrita.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena P Menon 
Designation  Professor 
Affiliation  Amrita Institute of Medical Sciences 
Address  Clinical Virology Lab Amrita Institute of Medical Sciences and Research Center, AIMS Ponekkara, Kochi.

Ernakulam
KERALA
682041
India 
Phone  8289874024  
Fax  04842802020  
Email  veenam20656@aims.amrita.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Vidya P Menon 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences 
Address  Dept of General Medicine Amrita Institute of Medical Sciences and Research Center, AIMS Ponekkara, Kochi.

Ernakulam
KERALA
682041
India 
Phone  04842851838  
Fax  04842802020  
Email  vidyamenon@aims.amrita.edu  
 
Source of Monetary or Material Support  
Micro Labs Limited, 27, Race Course Road, Bangalore - 560001 
 
Primary Sponsor  
Name  Micro Labs Limited 
Address  27, RACE COURSE ROAD, BANGALORE-560 001 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidya P Menon  Amrita Institute of Medical Sciences  Dept of General Medicine, Unit 4
Ernakulam
KERALA 
0484-2851838
0484-2852020
vidyamenon@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dengue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caripill  Carica Papaya Leaf Extract tablets 1100mg t.i.d for 5 days  
Comparator Agent  Placebo  1100mg t.i.d for 5 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Provide signed and dated informed consent form
2. Willing to comply with all study procedures and be available for the duration of the study
3. Male or female, aged greater than or equal to 18 yrs of age. Clinically diagnosed of dengue and a peripheral platelet count of less than or equal to 30,000/µL.
4. A laboratory positive diagnosis of dengue confirmed by a positive NS1 ELISA test and/or detection of viral RNA by real time PCR assay.
 
 
ExclusionCriteria 
Details  1. Pregnancy and lactation.
2. Patients who has been given steroids for thrombocytopenia and also those who have been transfused platelets before starting the drug
3. Taking indigenous medicines.
4. Creatine kinase (CK) >1000 U/L

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of peak platelet counts and hematocrit levels between the treatment and placebo groups.

Comparison of the frequency and type of blood product, more specifically platelet transfusions between the treatment and placebo groups.
 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of platelet counts with phases of dengue

Compare and evaluate the correlation of viremia with peripheral platelet counts between the treatment and placebo groups 
12 months 
 
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)   05/12/2016 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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   A placebo-controlled, single center, randomized prospective study of Caripill (Carica papaya leaf extract) tabs in dengue patients with severe thrombocytopenia (platelets < 30K/ul). The study will enroll 100 eligible dengue cases into the two arms of the study – one arm receiving Caripill 1100mg t.i.d for 5 days and the other group receiving placebo. The primary efficacy endpoints will be assessed by comparing the increase in the platelet counts and hematocrit levels during the hospital stay between the treatment and placebo groups. The peak platelet count and hematocrit will also be noted and compared between the treatment and the placebo group.  
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