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CTRI Number  CTRI/2015/05/005806 [Registered on: 25/05/2015] Trial Registered Prospectively
Last Modified On: 18/05/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A life saving measure for Dengue patients :Carica Papaya Leaf Extract 
Scientific Title of Study   A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue feverSafety of Carica Papaya Leaf Extract, as empirical therapy for 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  DrK H Nagabhushan 
Designation  Vice president -Medical services 
Affiliation  Mcro Labs Ltd 
Address  No 27 Race course road Bangalore 560001

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  khnagabhushan@microlabs.in  
 
Details of Contact Person
Scientific Query  
Name  DrK H Nagabhushan 
Designation  Vice president -Medical services 
Affiliation  Mcro Labs Ltd 
Address  No 27 Race course road Bangalore 560001


KARNATAKA
560001
India 
Phone    
Fax    
Email  khnagabhushan@microlabs.in  
 
Details of Contact Person
Public Query  
Name  DrKasture Prabhu 
Designation  Senior Manager-Medical servies 
Affiliation  Micro Labs Ltd 
Address  No 27 Race course road Bangalore 560001

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  kprabhu@microlabs.in  
 
Source of Monetary or Material Support  
Micro Labs Ltd No 27 Race course road Bangalore 560001 
 
Primary Sponsor  
Name  Micro Labs Ltd 
Address  No 27 Race course road Bangalore 560001 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAmbanna Gowda   Dr.B.R Ambedkar Medical college  Dr B R Ambedkar Medical College Department of medicine Ground floor Kadugondanahalli Bangalore 560045
Bangalore
KARNATAKA 		 09845270377

dr.ambanagowda@gmail.com 
DrVC Srinivas Reddy  King George Hospital  King George Hospital Ground floor Department of medicine KGH Down Rd, Jagadamba Area, Maharani Peta, Visakhapatnam, Andhra Pradesh 530001
Visakhapatnam
ANDHRA PRADESH 		 08912704848

kghreserch7@gmail.com 
Dr SPoorna Prasad  Prashanth Hospital  No.90/D Bommanahalli Circle, Hosur Main Road,Depart mentBengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 08041503714

prashanthhospitalresearch@gmail.com 
DrG Bharathi  Rajiv Gandhi Institute of Medical Sciences  Department of medicine Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH 		 08942279033

rimsresearch@gmail.com 
DrVijay kumar  Sri Venkateshwara Hospital  # 86,3rd floor department of medicine Hosur Road, NH 7, Madiwala, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 08040416789

svhospitalresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional ethics committee Dr.B.R Ambedkar Medical college and Hospital   Approved 
institutional ethics committee king george hospital  Approved 
institutional ethics committeeRajiv Gandhi Institute of Medical Sciences  Approved 
Prashanth Hospital Ethics Committee   Approved 
sri venkateswara hospital ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dengue patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carica Papaya leaf extract  Carica Papaya leaf extract (Caripill) per orally with a strength of 1100 mg tablet, three times a day for a period of 5 days as an adjuvant and the control group shall receive Placebo for the same frequency and duration as the intervention group. All the subjects shall be followed up daily for 5 days 
Comparator Agent  Placebo  Carica Papaya leaf extract (Caripill) per orally with a strength of 1100 mg tablet, three times a day for a period of 5 days as an adjuvant and the control group shall receive Placebo for the same frequency and duration as the intervention group. All the subjects shall be followed up daily for 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial,
2.Male and female patients above 18 years and below 60 years old,
3.Patients who were confirmed to have DF or DHF grade I and II,
4.Patients with a platelet count of less than 100,000/μL,
5.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 165U/L),
 
 
ExclusionCriteria 
Details  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   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in the platelet counts from the baseline levels to the end of therapy.  Increase in the platelet counts from the baseline levels to the end of therapy. 
 
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="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/06/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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

 
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