| CTRI Number |
CTRI/2025/09/095070 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of homoeopathic medicines in the management of urinary tract infection |
|
Scientific Title of Study
|
EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES VIS-A-VIS UVA URSI IN THE MANAGEMENT OF URINARY TRACT INFECTION: A RANDOMIZED COMPARATIVE 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 Goutami Choudhury |
| Designation |
PG SCHOLAR |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr M.P.K Homoeopathic Medical College Hospital and Research Centre Plot no. 10, 11, 12, Saipura Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
7820962625 |
| Fax |
|
| Email |
jimodogou@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Virendra Chauhan |
| Designation |
Professor and HOD |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr M.P.K Homoeopathic Medical College Hospital and Research Centre , Plot no. 10, 11, 12 Saipura Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
9983548853 |
| Fax |
|
| Email |
pmpg2724dept@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Goutami Choudhury |
| Designation |
PG SCHOLAR |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr M.P.K Homoeopathic Medical College Hospital and Research Centre Plot no. 10, 11, 12 Saipura, Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
7820962625 |
| Fax |
|
| Email |
jimodogou@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr MPK Homoeopathic Medical College, Hospital and Research Centre, Plot no. 10,11,12 Saipura, Sanganer, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Plot no. 10,11,12 Saipura, Sanganer, Jaipur, Rajasthan, 302029 |
| Type of Sponsor |
Private medical college |
|
|
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 Goutami Choudhury |
Dr Girendra Pal Homoeopathic Hospital |
Department of Practice of Medicine, OPD Room No. 1, Dr MPK Homoeopathic Medical College and Research Centre, A constituent college of Homoeopathy University , Plot No. 10,11,12 Saipura, Sanganer, Jaipur, Rajasthan Jaipur RAJASTHAN |
7820962625
jimodogou@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Homoeopathy University Jaipur |
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 |
| Comparator Agent |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
INDIVIDUALIZED HOMOEOPATHIC MEDICINES SELECTED ON THE BASIS OF TOTALITY OF SYMPTOMS OF EACH PATIENT.THE MEDICINE WILL BE ADMINISTERED ORALLY IN POTENCY 30C, 200C, 1M ACCORDING TO THE SUSCEPTIBILITY OF THE PATIENT AND AS PER THE PRINCIPLES GIVEN IN 5TH EDITION OF ORGANON OF MEDICINE. MEDICINE WILL BE ADMINISTERED IN GLOBULAR FORM OF SIZE 30, THREE TIMES A DAY WITH FOLLOW UP AFTER 14 DAYS, |
| Intervention |
UVA URSI |
UVA URSI WILL BE ADMINISTERED IN POTENCY 30C, 200C, 1M ACCORDING TO THE SUSCEPTIBILITY OF THE PATIENT AND AS PER THE PRINCIPLES GIVEN IN 5TH EDITION OF ORGANON OF MEDICINE. MEDICINE WILL BE ADMINISTERED ORALLY IN GLOBULAR FORM OF SIZE 30, THREE TIMES A DAY WITH FOLLOW UP AFTER 14 DAYS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of UTI.
Laboratory confirmation with positive urine culture and microscopic urine examination.
Patient of both sexes.
Patient who gave their consent for study. |
|
| ExclusionCriteria |
| Details |
Non cooperative or non compliant patients.
Patients suffering with impaired renal functions.
Patients suffering with gross pathological changes and malignancies or structural abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of individualized homoeopathic medicines and Uva ursi in the management of Urinary Tract Infection using UTISA questionnaire. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
30/09/2025 |
| 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 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 - NO
|
|
Brief Summary
|
AIM To compare the efficacy of homoeopathic individualized medicine and pre defined homoeopathic medicine Uva ursi in the management of Urinary Tract Infection. And to compare the improvement in patients of both groups using UTISA Questionnaire as an assessment scale. |