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CTRI Number  CTRI/2019/07/019965 [Registered on: 01/07/2019] Trial Registered Prospectively
Last Modified On: 18/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical evaluation of the effect of classical siddha drug karappāṉ kuá¹­inÄ«r cÅ«raṇam(internal) and koá¹­ivÄ“li eṇṇey(external) in the management of skin itching 
Scientific Title of Study   Clinical evaluation of the effect of KARAPPAN KUDINEER CHOORANAM(internal) and KODIVELI ENNAI(external) in the management of PORI KARAPPAN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  I BIBINA 
Designation  Post Graduate Student 
Affiliation  Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. 
Address  Department of Kuzhanthai Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9489262448  
Fax    
Email  22bibinaissac1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  D K Soundararajan 
Designation  Professor and Head 
Affiliation  Government Siddha Medical College & Hospital, Palayamkottai, Tirunelveli. 
Address  Department of Kuzhanthai Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442048801  
Fax    
Email  dr.dks.2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  D K Soundararajan 
Designation  Professor and Head 
Affiliation  Government Siddha Medical College & Hospital, Palayamkottai, Tirunelveli. 
Address  Department of Kuzhanthai Maruthuvam Government Siddha Medical College and Hospital Palayamkottai


TAMIL NADU
627002
India 
Phone  9442048801  
Fax    
Email  dr.dks.2012@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli 627002 
 
Primary Sponsor  
Name  I BIBINA 
Address  Department of Kuzhanthai Maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli- 627002 Tamil Nadu 
Type of Sponsor  Other [Self] 
 
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 
I BIBINA  Government siddha medical college and hospital, Palayamkottai  Room num 7 Department of Kuzhanthai Maruthuvam
Tirunelveli
TAMIL NADU 		 9489262448

22bibinaissa1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Siddha Medical College and Hospital Palayamkottai Tirunelveli-627002 Tamil Nadu India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L50||Urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  karappāṉ kuá¹­inÄ«r cÅ«raṇam(internal) and koá¹­ivÄ“li eṇṇey(external)  21 days Internal should be administrated orally 15-30 ml twice a day after food External should be apply externally  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  severe itching
erythema
vesicles
oozing
lichenification 
 
ExclusionCriteria 
Details  children above 12 years
urticarial rashes due to drug intake
FDE
urticarial associated with other severe form of dermatological disorder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
scaling, ertheyma, papules, vesiculation, oozing   15 days 
 
Secondary Outcome  
Outcome  TimePoints 
ESR
Total eosinophil count 		 21 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) 23/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 23/03/2020 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 The present study was performed as a single arm clinical trial to access the efficacy of karappāṉ kuá¹­inÄ«r cÅ«raṇam(internal) and  koá¹­ivÄ“li eṇṇey(external) in the management of pori karappāṉ. In this trial 40 patients were recruited and the trial drug were administered orally 15-30 ml twice a day after food and external application of oil for the period of 21 days. The primary outcome was accessed by changes in symptoms likeitching,erythema, papules, vesiculation, oozing and secondary outcome was accessed by the laboratory parameters like reduced ESR and absolute eosinophil count.

 
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