| CTRI Number |
CTRI/2025/09/094212 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on homoeopathic treatment in management of recurrent urinary tract in females of age group of 18 to 60 years. |
|
Scientific Title of Study
|
Evaluating the effectiveness of individualized homeopathic medicines using Synthesis Repertory edition 9.1 in the management of Recurrent Urinary Tract Infection in the females of age group 18 to 60 years |
| 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 Janhvi Balasaheb Pharande |
| Designation |
PG Student |
| Affiliation |
PG Scholar, Department of Repertory, Dr D Y Patil Homoeopathic Medical College And Research Centre |
| Address |
PG Scholar, Department of Repertory, Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7559133531 |
| Fax |
|
| Email |
janhvipharande20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janhvi Balasaheb Pharande |
| Designation |
PG Student |
| Affiliation |
PG Scholar, Department of Repertory, Dr D Y Patil Homoeopathic Medical College And Research Centre |
| Address |
PG Scholar, Department of Repertory, Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7559133531 |
| Fax |
|
| Email |
janhvipharande20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Arya |
| Designation |
Professor |
| Affiliation |
Professor and HOD, Department of Repertory, Dr D Y Patil Homoeopathic Medical College And Research Centre |
| Address |
HOD, Department of Repertory, Ground floor, Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422301824 |
| Fax |
|
| Email |
manish.arya@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Opd Ipd complex Department of Homoeopathic Repertory and Case Taking, Ground floor, Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janhvi Balasaheb Pharande |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Nagar Pimpri Pune INDIA |
OPD IPD COMPLEX 1ST FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
Pune
MAHARASHTRA |
7559133531
janhvipharande20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College And Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Individualised Homoeopathic Medicine |
Dose centicimal scale
Frequency TDS
Route of administration Oral
Duration 6 months |
| Comparator Agent |
NIL |
NIL as single arm Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients with positive urinalysis showing elevated pus cell count
Clinically diagnosed cases of urinary tract infection
History of urinary tract infection ie occurrence of at least one episode in last 6 months or two in last one year
|
|
| ExclusionCriteria |
| Details |
Patients with indwelling catheter use
Patients with gross pathology like pyelonephritis and structural abnormalities like strictures
Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the number of pus cells in urinalysis before and after the treatment |
Baseline fortnightly till end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Recurrent Urinary Tract assessment Scale & to reduce the no of episodes of recurrent urinary tract infection |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This study is a
single-arm experimental study to evaluate the effectiveness of individualized
homeopathic medicines in management of recurrent urinary tract infection in
women aged 18 to 60 years These medicines will be chosen using the Synthesis
Repertory Edition 9dot1 The study will take place at the outpatient and
inpatient departments of Dr D Y Patil Homoeopathic Medical College and Research
Centre over 18 months We will select 50 patients who meet the inclusion
criteria through purposive sampling Data will be gathered through detailed
case-taking, clinical examination and laboratory diagnosis |