FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013644 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 02/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   a study on siddha trail drug KUTTATHIRKU CHOORANAM (INT) & VEPPAMPATTAI THYLAM (EXT) & PRANAYAAMAM (THERAPY) in patients having psoriasis 
Scientific Title of Study   AN OPEN CLINICAL TRAIL ON “THEATHRU KUTTAM (PSORIASIS)” WITH THE EVALUATION ON SIDDHA HERBO-MINERAL FORMULATION KUTTATHIRKU CHOORANAM (INT) & VEPPAMPATTAI THYLAM (EXT) & PRANAYAAMAM (THERAPY). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Thirugnanam 
Designation  PG scholar 
Affiliation  government siddha medical college chennai  
Address  Post graduate department of sirappu maruthuvam, Siddha medical college no 6 anna arch road, NSK nagar arumbakkam, chennai

Chennai
TAMIL NADU
600106
India 
Phone  8122462463  
Fax    
Email  rk.thiru73@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Sekar 
Designation  Grade II Lecturer 
Affiliation  government siddha medical college chennai  
Address  Room no 4 Department of sirappu maruthuvam Govt Siddha medical college no 6 anna arch road NSK nagar, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9786193863  
Fax    
Email  guidesekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Thirugnanam 
Designation  PG scholar 
Affiliation  government siddha medical college chennai  
Address  Post graduate department of sirappu maruthuvam siddha medical college no 6 anna arch road, NSK nagar, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  8122462463  
Fax    
Email  rk.thiru73@gmail.com  
 
Source of Monetary or Material Support  
government siddha medical college no 6 anna arch road nsk nagar arumbakkam chennai  
 
Primary Sponsor  
Name  government siddha medical college 
Address  no 6 anna arch road nsk nagar arumbakkam chennai  
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 K Thirugnanam  arignar anna hospital of indian medicine   room no 4 siddha division POst graduate department of sirappu maruthuvam siddha medical college no 6 anna arch road nsk nagar arumbakkam chennai tamil nadu
Chennai
TAMIL NADU 
8122462463

rk.thiru73@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical comitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  THEATHRU KUTTAM (PSORIASIS),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KUTTATHIRKU CHOORANAM(INT) & VEPPAMPATTAI THYLAM (EXT)   8oo mg of KUTTATHIRKKU CHOORANAM for 48 days as internal medicine and Veppampattai thylam (external) for 48 days as external medicine 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patches with Scaling
Auspitz Sign positive
Koebner’s Phenomenon positive.
 
 
ExclusionCriteria 
Details  Psoriasis with secondary infection in the lesions
Alcoholism & Narcotic addicts
History of long term intake of Steroids
Cardiac disease
Renal failure
Pregnancy women and Lactating women
Peptic ulcer
Psoriatic Orthopedica
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
outcome is mainly assessed by reduction in clinical symptoms like itching and scaling.PASI Score (Psoriasis area severity index)  12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   06/05/2018 
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)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is an open clinical study to evaluate the efficacy of KUTTATHIRKU CHOORANAM (INT) VEPPAMPATTAI THYLAM (EXT) .8oomg of KUTTATHIRKU CHOORANAM and sufficient quantity of VEPPAMPATTAI THYLAM will be given for 48 days. PRANAYAAMAM (THERAPY) is given for all the patients.sample size is 40.the trail drugs KUTTATHIRKU CHOORANAM (INT) VEPPAMPATTAI THYLAM (EXT) contains  some herbs and metals  having anti-oxidant,immune modulator  properties which will be helpful to manage psoriasis 
Close