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CTRI Number  CTRI/2024/06/069062 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Siddha medicine Vaazhaipoo nei (internal) for Akkaram (Apthous Stomatitis) 
Scientific Title of Study   Phase II Non-randomized clinical study on Akkaram (Apthous Stomatitis) with the evaluation of Siddha trial drug Vazhai poo nei (internal) in children. 
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 Abirami R 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College Arumbakkam Chennai 
Address  Post graduate Room number 25, Department of Kuzhanthai Maruthuvam, Government Siddha Medical College, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  6383872631  
Fax    
Email  abiramiram97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Manju Hemamalini 
Designation  Associate Professor, UG HOD, Department of Kuzhanthai Maruthuvam 
Affiliation  Government Siddha Medical College Arumbakkam Chennai 
Address  Post graduate Room number 25, Department of Kuzhanthai Maruthuvam, Government Siddha Medical College, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9894325360  
Fax    
Email  mahema.siddha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abirami R 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College Arumbakkam Chennai 
Address  Post graduate Room number 25, Department of Kuzhanthai Maruthuvam, Government Siddha Medical College, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  6383872631  
Fax    
Email  abiramiram97@gmail.com  
 
Source of Monetary or Material Support  
Arignar Anna Government Siddha Medical College, No-6-Anna Arch Road, Arumbakkam, Chennai,600106 
 
Primary Sponsor  
Name  Government Siddha Medical College 
Address  No 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 
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 Abirami R  Government Siddha Medical College  Room No.25, Department of Kuzhanthai Maruthuvam, Arignar Anna Government Hospital NSK nagar Arumbakkam, Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 6383872631

abiramiram97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Siddha Medical College, Arumbakkam, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K12||Stomatitis and related lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NIl 
Intervention  Vazhai poo nei (internal)  Vazhai poo nei 1 -2 grams twice a day for 7 - 14 days. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Ulceration in the oral cavity (up to Grade III of WHO oral mucositis scale)
2.Blisters in the mouth
3.Pallor
4.Fever  
 
ExclusionCriteria 
Details  1. Traumatic ulcer
2. Chemical burns
3. Oral ulcer due to cancer
4. Grade IV ulcer (WHO oral mucositis scale)
5. Secondary syphilitic ulcer
6. Herpetic gingivostomatitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of clinical symptoms (like blisters in mouth, pallor, ulceration)
Comparation with WHO oral mucositis scale 		 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
It is assessed by comparing the safety parameters before & after treatment  10 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)   03/10/2024 
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   N/A 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [abiramiram97@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 30-11-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a single Non-randomized open clinical trial to study the safety and efficacy of Siddha trial drug Vazhai poo nei (internal) in treating  Akkaram(apthous stomatitis). The trial drug is to be given 1-2 grams twice a day for 7-14 days. Clinical trial is to be conducted after conducting pre-clinical study. The trial drug Vazhai poo nei has been mentioned in Pararasasekaram Bala Roga Nidhanam. During the trial study the related data will be recorded and documented. Post the completion of trial the data will be statistically analyzed. 
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