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CTRI Number  CTRI/2024/07/070059 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Padarthamarai(Tinea corporis)-An oral administration of siddha classical drug Padai sankaaran(External) 
Scientific Title of Study   A Case series on assessment of effectiveness of padai sankaaran(External) in the treatment of padarthamarai (Tinea corporis) among patients,attending OPD,Government siddha medical college and hospital,Palayamkottai  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Sathiyaseelan 
Designation  PG scholar 
Affiliation  Government Siddha Medical College and Hospital,palayamkottai 
Address  OP NO. 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.

Tirunelveli
TAMIL NADU
627002
India 
Phone  8838637992  
Fax    
Email  sathiyastar4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Sathish kumar 
Designation  Lecturer 
Affiliation  Government Siddha Medical College and Hospital 
Address  PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.

Tirunelveli
TAMIL NADU
627002
India 
Phone  9944337757  
Fax    
Email  drpsk_md@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr T Komalavalli  
Designation  Head Of The Department 
Affiliation  Government Siddha Medical College and Hospital 
Address  PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.

Tirunelveli
TAMIL NADU
627002
India 
Phone  9788122691  
Fax    
Email  komalaarumugam1@gmail.com  
 
Source of Monetary or Material Support  
OPD and IPD facilities and central Library of Government siddha medical College and hospital, Thiruvananthapuram main road, Palayamkottai, Tirunelveli -627002, Tamilnadu,India 
 
Primary Sponsor  
Name  Government Siddha Medical College and Hospital  
Address  PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital Palayamkottai, Tirunelveli-627 002, Tamilnadu, India  
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 R Sathiyaseelan  Government Siddha Medical College and Hospital   PG Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627 002, Tamilnadu, India
Tirunelveli
TAMIL NADU 		 8838637992

sathiyastar4@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   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (2) ICD-10 Condition: B354||Tinea corporis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Padai sankaaran  Required dosage externally for 30 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who are having classical symptoms of single or multiple scaly annular lesions, with slightly raised erythematous edge with central clearing in body  
 
ExclusionCriteria 
Details  Presence of any other skin disease that may affect outcome of study like,
1.Contact dermatitis
2.Nummular eczema
3.Plaque psoriasis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome will be aimed at reducing the symptoms such as scaling,Itching, erythema,margin continuity in padarthamarai(Tinea corporis) and to determine the therapeutic efficacy of clinical trial drug (Padai sankaaran-External)  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the clinical symptoms by using lesion severity score before and after treatment   30 days  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   13/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is A CASE SERIES ON ASSESSMENT OF EFFECTIVENESS OF PADAI SANKAARAN IN THE TREATMENT OF PADARTHAMARAI (TINEA CORPORIS) AMONG PATIENTS , ATTENDING OPD, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI. This trial drug at required dosage(externally) for 30 days for 20 OP patients. The trial period of 4 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu.The outcome will be aimed at reducing the symptoms of Padarthamarai(Tinea Corporis)and to determine the therapeutic efficacy of clinical trials drug(Padai Sankaaran). The secondary outcome will be aimed at reducing the clinical symptoms by using Lesion Severity Score (before & after treatment). 
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