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CTRI Number  CTRI/2018/07/014869 [Registered on: 13/07/2018] Trial Registered Prospectively
Last Modified On: 16/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   A clinical trail to study the effects of karappan kudineer chooranam (internal) and karappan ennai (external ) in patients with sattai karappan  
Scientific Title of Study   An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation karappan kudineer chooranam (internal ) and karappan ennai (external )for the treatment of sattai karappan 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A AMMU 
Designation  PG Scholar 
Affiliation  goverment siddha medical college and hospital palayamkottai 
Address  OP NO 7 post graduate department of kuzhanthai maruthuvam
OP NO 7 post graduate department of kuzhanthai maruthuvam
Tirunelveli
TAMIL NADU
627002
India 
Phone  9629847962  
Fax    
Email  madhi1493@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  D K SOUNDARA RAJAN 
Designation  professor 
Affiliation  goverment siddha medical college and hospital palayamkottai 
Address  OP NO 7 post graduate department of kuzhanthai maruthuvam
OP NO 7 post graduate department of kuzhanthai maruthuvam
Tirunelveli
TAMIL NADU
627002
India 
Phone  9442048801  
Fax    
Email  dr.dks2012@gmail.com  
 
Details of Contact Person
Public Query
 
Name  A AMMU 
Designation  PG Scholar 
Affiliation  goverment siddha medical college and hospital palayamkottai 
Address  OP NO 7 post graduate department of kuzhanthai maruthuvam
OP NO 7 post graduate department of kuzhanthai maruthuvam
Tirunelveli
TAMIL NADU
627002
India 
Phone  9629847962  
Fax    
Email  madhi1493@gmail.com  
 
Source of Monetary or Material Support  
IPD and OPD government siddha medical college and hospital Palayamkottai 
Library government siddha medical college and hospital palayamkottai 
 
Primary Sponsor  
Name  A AMMU  
Address  Government siddha medical college and hospital palayamkottai 
Type of Sponsor  Other [PG scholar (stif fund)] 
 
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 
A AMMU  Goverment siddha medical college and hospital  OP NO 7 post graduate department of kuzhanthai maruthuvam
Tirunelveli
TAMIL NADU 
9629847962

madhi1493@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutiional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  sattai karappan,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Karappan kudineer chooranam(internal)karappan ennai(external)  3-7 years 30ml,7-12 years 60ml,twice a day (morning and evening)internally and Oil-externally. 
Comparator Agent  not applicable  not applicable  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patient with appropriate symptoms of intense itching erythema papules papulovesicles crusted lesion all over the body ulceration exudation constipation 
 
ExclusionCriteria 
Details  children above 12 years scabies psoriasis secondary bacterial infection nummular dermatitis contact dermatitis seborric dermatitis furunculosis photo dermatitis neuro dermatitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal)karappan ennai (external)on Sattai karappan  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of siddha diagnostic parameters  21 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)
Modification(s)  
17/07/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/07/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is  prospective open labeled non randomized phase 2 an open clinical study to evaluate the clinical efficacy of siddha sasthric formulation Karappan kudineer chooranam(internal) Karappan ennai (external) 3-7 years 30ml,7-12years 60ml,twice a day (morning and evening)internally and Oil-externally for 21 days in 40 patients during the trail period of 13months that will be conducted in government siddha medical college and hospital palayamkottai Tamil nadu The primary outcome will be the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal) karappan ennai(external)on Sattai karappan The secondary outcome will be the evaluation of siddha diagnostic parameters 
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