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CTRI Number  CTRI/2024/09/074102 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 14/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Other 
Public Title of Study   A study to understand effects of Homoeopathic medicine in urinary tract infection of children  
Scientific Title of Study   A prospective study on the effectiveness of individualized homoeopathic medicine in the treatment of acute urinary tract infection in paediatric cases. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshaya P 
Designation  Pg scholar  
Affiliation  Dr MGR Medical University White Memorial Homoeo Medical College and Hospital  
Address  White Memorial Homoeo Medical College and Hospital ATTOOR Veeyanoor P O Kanniyakumari district Tamilnadu

Kanniyakumari
TAMIL NADU
629177
India 
Phone  8281669561  
Fax    
Email  sajindrakshaya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Judin stephenson 
Designation  Associate Professor of Department of Paediatrics  
Affiliation  White Memorial Homoeo Medical College and Hospital  
Address  Department of Paediatrics White Memorial Homoeo Medical College and Hospital ATTOOR Veeyanoor P O Kanniyakumari district Tamilnadu

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9538484284  
Fax    
Email  judzon3535@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akshaya P 
Designation  Pg scholar  
Affiliation  White Memorial Homoeo Medical College and Hospital  
Address  White Memorial Homoeo Medical College and Hospital ATTOOR Veeyanoor P O Kanniyakumari district Tamilnadu

Kanniyakumari
TAMIL NADU
629177
India 
Phone  8281669561  
Fax    
Email  sajindrakshaya@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics, White Memorial Homoeo Medical College and Hospital ATTOOR Veeyanoor P O kanniyakumari district Tamilnadu  
 
Primary Sponsor  
Name  White Memorial Homoeo medical college and Hospital  
Address  White Memorial Homoeo medical college and Hospital ATTOOR Veeyanoor PO Tamilnadu 629177 
Type of Sponsor  Private 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 Akshaya P   White Memorial Homoeo medical College and Hospital   Department of Paediatrics OPD Unit,IPD unit, Peripheral centres and School health
Kanniyakumari
TAMIL NADU 		 8281669561

sajindrakshaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL   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 
Intervention  Homoeopathic medicine   Individualised medicine selected based on Totality of symptoms will be given in aqua dose in 200 CH, 1 ml of medicine will be given 6 hourly till symptoms subsided. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Female 
Details  Patients of females
Those cases with pus cells and urine routine examination
Pus cells greater than 10 per HPF 
 
ExclusionCriteria 
Details  Patients with other systematic illness
Patients with age more than 10 yrs
Patients with age less than 5 yrs
Male patients
Girls attain their menarche
Patients with compromised immune system
Patients suspected or confirmed structural abnormalities  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Each cases is assessed by change in pus cells greater than 10 percentage 3days once  Urine routine examination will be repeated every three days  
 
Secondary Outcome  
Outcome  TimePoints 
Each case is assessed with improvement in pus cells in greater ten percentage.  6 months  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/09/2024 
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 Yet Recruiting 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

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

  6. For how long will this data be available start date provided 04-06-2026 and end date provided 04-06-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Minimum of 60 cases selected for purposive sampling 
Cases will be taken in detail and recorded in the White Memorial Homoeopathic Medical College and Hospital pre structured standardized case record
Diagnosis will be done by clinical symptoms and urine routine examination
Analyzed case will be individualized and suitable individualized Homoeopathic medicines will be selected 
Changes in the symptoms will be noted
Urine routine examination will be repeated every three days until complete symptomatic relief of patient
 
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