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CTRI Number  CTRI/2018/04/013381 [Registered on: 19/04/2018] Trial Registered Retrospectively
Last Modified On: 04/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical trial to study the efficacy of Karappan Ennai in Karappan(Atopic Dermatitis) 
Scientific Title of Study   An Open Non-Randomized Clinical trial to Evaluate the Efficacy of Karappan Ennai in Karappan (Atopic Dermatitis) Among Children Between 3-12years. 
Trial Acronym  Kp Ennai 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeshwari E 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai

Chennai
TAMIL NADU
600106
India 
Phone  7200695637  
Fax    
Email  dr.rajeshwari92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gandhimathi S 
Designation  lecturer  
Affiliation  Government Siddha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Government siddha medical college 6 Anna arch road NSK Nagar Arumbakkam chennai 600 106
Chennai
TAMIL NADU
600106
India 
Phone  9840788777  
Fax    
Email  sgmathi16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeshwari E 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai

Chennai
TAMIL NADU
600106
India 
Phone  7200695637  
Fax    
Email  dr.rajeshwari92@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 
 
Primary Sponsor  
Name  Government Siddha Medical College 
Address  Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 
Type of Sponsor  Government medical college 
 
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 Rajeshwari E  Aringar Anna Government Hospital of Indian Medicine  Room No 20 Siddha Department Aringar Anna Hospital 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106
Chennai
TAMIL NADU 		 7200695637

dr.rajeshwari92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Communication of the Decision of Institutional Ethics Committee   Approved 
Communication of the Decision of Institutional Ethics Committee   Approved 
Institutional Ethical Committe  Approved 
Institutional Ethical Committe  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Karappan(Atopic dermatitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Karappan Ennai  15ml oil is Externally applied over the karappan lesions for 15 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age 3-12years
sex:Both male and female children
severe itching with scartching
Erythema
papules with oedema
Vesicles
Oozing
Crusting
Scaling
Lichenification
Patients willing to fill concent/assent form
Patients willing to take Photograph before and After treatment
patients who are all willing to give blood samples at subsequent visit are involved in this study 
 
ExclusionCriteria 
Details  Scabies
Photo dermatitis
Ichthyosis
Pityriasis alba
Cheilitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is reduction in EASI Score.Reduction in clinical symptoms like Erythema, Thickness,Severe itchinh,lichenification.Photos of the patient before and after treatment for the evidence of the clinical improvement  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
It is assessed by comparing the safety parameters before and after treatment  15 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   17/06/2017 
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)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a open non randomized clinical trial to study the safety and efficacy of siddha trial drug karappan ennai(official siddha herbal formulation) in karappan(Atopic dermatitis) among children between 3-12 years. This trial drug is 15ml oil is externaly applied over the karappan lesions for children for 15 days. The clinical trial is conducted after counducting preclinical toxicity study. The trial drug karappan Ennai is mentioned in Agathiyar vaithiya vallathi 600. During the trial all the study realated data will be recorded and documented. After the completion of trial all the data will be analysed statistically. 
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