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CTRI Number  CTRI/2018/04/013087 [Registered on: 06/04/2018] Trial Registered Retrospectively
Last Modified On: 28/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A study on Elathy chooranam(internal medicine) and Pathirasara virana puchu thailam(external medicine)in patients having ulceration present in the lower leg. 
Scientific Title of Study   Evaluation of therapeutic efficacy of Elathy chooranam(internal medicine) and Pathirasara virana poochu thailam (external medicine)in the treatment of Silai pun (varicose ulcer) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PON LOGANATHAN 
Designation  Pg Scholar 
Affiliation  National institute of Siddha  
Address  Room No 3, Dept of Sirappu maruthuvam Ayothidoss Pandithar Hospital National Institute of Siddha Chennai

Chennai
TAMIL NADU
600047
India 
Phone  7418240820  
Fax    
Email  drlogan7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N J Muthukumar 
Designation  Head Of The Department 
Affiliation  National institute of siddha 
Address  Dept of Sirappu maruthuvam Ayothidoss Pandithar Hospital National Institute of Siddha Chennai

Chennai
TAMIL NADU
600 047
India 
Phone  9962006843  
Fax    
Email  njmuthu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pon Loganathan 
Designation  PG Scholar 
Affiliation  National institute of siddha 
Address  Dept of Sirappu maruthuvam Ayothidoss Pandithar Hospital National Institute of Siddha Chennai

Chennai
TAMIL NADU
600 047
India 
Phone  7418240820  
Fax    
Email  drlogan7@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No 3, Dept of Sirappu maruthuvam Ayothidoss Pandithar Hospital National Institute of Siddha 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 Pon Loganathan  National institute of siddha  Department of Sirappu Maruthuvam Ayothidoss pandithar hospital National institute of siddha Tambaram sanatorium chennai
Kancheepuram
TAMIL NADU 		 7418240820

drlogan7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee National Institute of Siddha Tambaram Sanatorium  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with the complaints of ulcers with varicose veins,with or without pain,itching,edema,fibrinous exudates in the lesions,hyperpigmentation,eczema around the ulcer,inflammation and induration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ELATHY CHOORANAM(internal) and PATHIRASARA VIRANA PUCHU THAILAM(external)  ELATHY CHOORANAM is a polyherbal formulation in a dosage of 1.5g twice a day after food with milk for 45 days. PATHIRASARA VIRANA PUCHU THAILAM is applied externaly in the ulcer 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Presence of ulcers with varicose veins
•With or without Pain, Itching, Edema, Fibrinous exudates in the lesions
•Hyper pigmentation
•Eczema around the ulcer
•Inflammation & Induration

 
 
ExclusionCriteria 
Details  •Diabetes Mellitus.
•Hansen’s disease.
•Diabetic ulcer
•Gangrene
•Tuberculous ulcer
•Any other systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of Ulcers  1-45 days 
 
Secondary Outcome  
Outcome  TimePoints 
•Reduction of associated symptoms of Varicosity
•The basic siddha principles will be assessed before and after the treatment. 		 1-45 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)   27/07/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a single arm trial to evaluate the efficacy of  Elathy chooranam and Pathirasara virana puchu thailam in the treatment of Silai pun (varicose ulcer) in adults. The trial drug Elathy chooranam with milk as adjuvant and Pathirasara virana poochu thailam as external appication is administered for 45 days. The study has got approval of Institutional Ethics Committee.  
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