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CTRI Number  CTRI/2022/11/047671 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [Intervention study ]  
Study Design  Single Arm Study 
Public Title of Study   Treatment for Kanakadi (Urticaria) by using Gandhaga rasayanam and Arugan thylam 
Scientific Title of Study   A Clinical evaluation of Siddha formulation Gandhaga rasayanam(Internal medicine) and Arugan thylam(External medicine) for Kaanakadi(Urticaria) 
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 S MANJU 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 6 Department of Nanju maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9498073226  
Fax    
Email  manjukrishnaveni04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R MADHAVAN 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no 6 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  Dr S MANJU 
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Room no 6 Department of Nanju maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai
Room no 6 Department of Nanju maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India 
Phone  09498073226  
Fax    
Email  manjukrishnaveni04@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram sanatorium Chennai -47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss Pandithar Hospital 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 
S MANJU  National Institute of Siddha  OP NO 6 Department of Nanju maruthuvam Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram sanatorium Chennai -47
Chennai
TAMIL NADU 		 09498073226

manjukrishnaveni04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L509||Urticaria, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gandhaga rasaayanam (internal medicine) and Arugan thylam (external medicine)  Gandhaga rasaayanam 6g bd with Milk Arugan thylam 20ml for external applications  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with clinical symptoms of
Itching
Redness
Pale pink oedematous wheal
Wheals surrounded by flare
Inflamation
Erythematous macules (any 2 symptoms especially itchy,wheal)
Recurrent episodes of urticaria  
 
ExclusionCriteria 
Details  Any serious systemic illness
Psoriasis
Eczema
Tinea infection
Pregnancy
Lactation
Psychological factor
Adverse reaction of any drug 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Gandhaga rasayanam(internal) and arugan thylam(external) in the management of urticaria will be assessed by based on urticaria activity score(UAS) and IgE in study subjects before and after the treatment.  48 Days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/11/2022 
Date of Study Completion (India) 10/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/05/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-08-2022 and end date provided 25-12-2022?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The aim to evaluate the effective of Gandhaga Rasayanam(internal) and Arugan thylam(external) in the management of kaanaakadi (urticaria).To assess the therapeutic efficacy of Siddha formulation Gandhaga Rasayanam and Arugan thylam in the management of kaanaakadi. This trial drug will be issued to the patient .The patient will be asked to visit OPD of Ayothidoss pandithar hospital National institute of Siddha with 40 patients once 10 days for clinical assessment.  Patient selected based on inclusion and exclusion criteria. Laboratory investigation taken before and after treatment. All the data entered into computer and analysed. All collected data will be statistically analysed by Research officer (statistics) for logical errors and incompleteness of data to avoid any bias.Then final report will be generated.The outcome will be assessed by based on Urticaria Activity Score and IgE before and after treatment. 
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