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CTRI Number  CTRI/2025/05/086184 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study on Vallarai Chooranam in the management of Azhal Neerchurukku(Urinary Tract Infection) 
Scientific Title of Study   SINGLE CENTRIC NON RANDOMISED OPEN CLINICAL TRIAL PHASE II IN AZHAL NEERCHURUKKU(URINARY TRACT INFECTION)WITH SIDDHA MEDICINE VALLARAI CHOORANAM AMONG PATIENTS ATTENDING OPD AT GOVERNMENT SIDDHA MEDICAL COLLEGE HOSPITAL,CHENNAI 
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 Priyanka S 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College,Chennai 
Address  Department of PG Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9500179263  
Fax    
Email  priya22sathya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhamathi Pushparaj 
Designation  Head of the Department,Professor 
Affiliation  Government Siddha Medical College,Chennai 
Address  Department of PG Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9445118473  
Fax    
Email  sudhamathipushparaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudhamathi Pushparaj 
Designation  Head of the Department,Professor 
Affiliation  Government Siddha Medical College,Chennai 
Address  Department of PG Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai

Chennai
TAMIL NADU
600106
India 
Phone  9445118473  
Fax    
Email  sudhamathipushparaj@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Arumbakkam, Chennai 600106 
 
Primary Sponsor  
Name  Government Siddha Medical College, Chennai 
Address  No 6,Anna Arch Road,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 Priyanka S  Government Siddha Medical College Hospital,Chennai  Department of PG Pothu Maruthuvam,Room NO S1,Government Siddha Medical College Hospital,Chennai
Chennai
TAMIL NADU 		 9500179263

priya22sathya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics 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: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Vallarai Chooranam  The medicine will be given 1.5 gms,twice a day for 40 days with Ghee 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having complaints such as
Dysuria, Frequency of micturition, Burning micturition, Hematuria , Lower abdominal pain,
Low backache / supra pubic pain, patients with urine culture significant for bacteria or fungus,Patients having moderate to severe symptoms according to UTI symptom assessment scale
 
 
ExclusionCriteria 
Details  Pregnancy
H/O Sexually transmitted disease
H/O Malignancy
H/O Diabetes mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It is mainly assessed by reduction in Clinical Signs and Symptoms by UTI Symptom assessment score and also assessed by Urine Culture when bacterial/fungal infection becomes negative after treatment   40 days 
 
Secondary Outcome  
Outcome  TimePoints 
By Comparing the Clinical Signs and Symptoms and the Urine Culture before and after treatment   40 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)   20/05/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Researchers who provide a methodologically sound proposal.

  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 [priya22sathya@gmail.com].

  6. For how long will this data be available start date provided 12-05-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Urinary tract infection is the presence of microbial pathogens in the urinary tract. The incidence is high common among women.  The common feature of UTI are frequency of micturition and urgency,oliguria,dysuria.In siddha system of medicine there are unique combination of medicine one such combination of medicine is Vallarai chooranam which will be more effective and reliable . 
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