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CTRI Number  CTRI/2025/08/092659 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of homoeopathic antimiasmatic medicines in preventing recurrent Urinary Tract Infection in women of reproductive age 
Scientific Title of Study   Role Of Homoeopathic Antimiasmatic Medicines In Preventing Recurrence Of UrinaryTract Infection In Women Of Reproductive Age Group- A Quasi Experimental Study. 
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 Haseena A K 
Designation  Post graduate scholar 
Affiliation  Goverment Homoeopathic Medical College Kzhikode 
Address  Department Of Homoeopathic Philosophy Government Homoeopathic Medical College karaparamba Kozhikode Kerala India
Vadackayil House Purangu Pallippadi
Malappuram
KERALA
673010
India 
Phone  9539099869  
Fax    
Email  haseenaak905@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smitha Madhavan 
Designation  Guide 
Affiliation  Government Homoeopathic Medical college karaparamba kozhikode 
Address  Government Homoeopathic Medical college karaparamba kozhikode

Kozhikode
KERALA
673010
India 
Phone  9349731235  
Fax    
Email  drsmithamadhavan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smitha Madhavan 
Designation  Guide 
Affiliation  Government Homoeopathic Medical college karaparamba kozhikode 
Address  Government Homoeopathic Medical college karaparamba kozhikode

Kozhikode
KERALA
673010
India 
Phone  9349731235  
Fax    
Email  drsmithamadhavan@gmail.com  
 
Source of Monetary or Material Support  
Government homoeopathic medical college karaparamba Kozhikode Kerala India Pin 673010  
 
Primary Sponsor  
Name  Dr Haseena AK 
Address  Post Graduate Scholar Department Of Homoeopathic Medical College Karaparamba Kozhikode India Pin 673010 
Type of Sponsor  Other [Self] 
 
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 Haseena A K  Government Homoeopathic Medical college  Department Of Homoeopathic Philosophy Government Homoeopathic Medical College Kozhikode
Kozhikode
KERALA 		 09539099869

haseenaak905@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committeeKaraparambaKozhikode  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 Antimiasmatic medicine  Patients coming with acute presentation of UTI, will be managed with individualised Homoeopathic medicines and after retaking the case, appropriate antimiasmatic medicine will be given during the symptom free interval.Follow up of case will be taken in 3 weeks and maximum duration of study 1 year. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Female cases aged from 15-45 yrs
Cases satisfying diagnostic criteria 
 
ExclusionCriteria 
Details  Patients with diabetes
Patient with renal pathology
Patients with indwelling catheter
Patients with immune suppressive treatment pregnancy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Number of recurrence in 6 months and
Symptom History Urine analysis score.
 		 Each cases will be reviewed at 2to 3 weeks interval and followed for 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 3 
Date of First Enrollment (India)   26/08/2025 
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="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 -  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 - Proposals should be directed to [haseenaak905@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Patients satisfying the diagnostic criteria will be subjected to a detailed case taking and miasmatic predominance of Patient will be assessed using philosophy of  J,H.Allen and based on Theory of chronic disease of Hahnemann,and books of  various authers.In case of Patients coming with acute presentation of UTI, will be  managed with individualised Homoeopathic medicines and after retaking the case appropriate antimiasmatic medicine will be given during the symptom free interval.
 
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