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CTRI Number  CTRI/2025/02/080424 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 09/02/2025
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 Sivappu Kukil Thylam (External Medicine) in the management of Kaanakadi (Urticaria) 
Scientific Title of Study   An Open Label Single Arm Clinical Trial to evaluate the Effectiveness of Elathy Chooranam (Internal Medicine) and Sivappu Kukil Thylam (External Medicine) in the management of Kaanakadi (Urticaria) among patients reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha  
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 Shaira Banu I 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room NO:26/27 Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9790875812  
Fax    
Email  shairabanuismail12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr R Madhavan 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Room NO:26/27 Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9965561656  
Fax    
Email  drmadhavanji@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr R Madhavan 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Room NO:26/27 Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9965561656  
Fax    
Email  drmadhavanji@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no:26/27, National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
Type of Sponsor  Research institution and hospital 
 
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 Shaira Banu I  Ayothidoss Pandithar Hospital, National Institute of Siddha  Room no:26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Chennai
TAMIL NADU 		 9790875812

shairabanuismail12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NATIONAL INSTITUTE OF SIDDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L50||Urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Elathy Chooranam  Internal Medicine: Dose: 3 Tablets - Twice a day, Adjuvant - Warm water, Duration: 40 days 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Sivapppu Kukil Thylam  External application for 40 days. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants with clinical symptoms of itching, burning sensation, erythema, pale pink oedematous wheal formation, wheals surrounded by flare. 
 
ExclusionCriteria 
Details  Evidence of any skin condition other than urticaria, angioedema, narcotic addicts, pregnancy and lactation, diabetes mellitus, hypertension. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant reduction in clinical symptoms based on Urticaria Activity Score over 7 days (UAS7) and clinical laboratory blood parameters such as IGE, AEC, ESR, CRP  3 Months -Screening
12 Months - Patient enrollment
3 Months -Outcome assessment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/02/2025 
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="6"
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   BACKGROUND: 
       Urticaria is an inflammatory disorder that affects up to 20% of the world’s population at some point during their life. It is a dermal vascular reaction of the skin characterized by the appearance of pruritic wheals, elevated, pale or eruthematous, transient, and evanescent plaque lesions due to dermal edema. These lesions usually do not stay beyond 24 hours.

OBJECTIVE: 
  • To evaluate the changes in clinical symptoms by using urticaria activity score over 7 days.
  • To evaluate the changes in clinical laboratory blood parameters such as IGE, AEC, ESR, and CRP before and after treatment.
CONDUCT OF THE STUDY:
  • Study place: Interventional study
  • Study design: An open clinical trial - single-arm
  • Sampling method: Consecutive sampling
OUTCOME: 
        Significant reduction in clinical symptoms based on urticaria activity score over 7 days and clinical laboratory blood parameters such as IGE, AEC, ESR, and CRP before and after treatment.


 
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