| CTRI Number |
CTRI/2025/02/080658 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathic medications in cases of urinary tract infections |
|
Scientific Title of Study
|
Role of individualised homoeopathic medicine in urinary tract infections - an in-vitro and pre-post, single arm clinical trial |
| 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 Ezhilmathi K S |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9688907467 |
| Fax |
|
| Email |
ezhilmathishanmugam37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ezhilmathi K S |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9688907467 |
| Fax |
|
| Email |
ezhilmathishanmugam37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratima Pal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
7679507608 |
| Fax |
|
| Email |
dr.pratimapal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy GE block Sector 3 Kolkata 700106 India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia medica OPD Room no 18 |
| Type of Sponsor |
Government 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 Ezhilmathi K S |
National institute of homoeopathy |
OPD 18 Department of Homoeopathic Materia medica GE
Block Sector 3 Salt lake Kolkata West Bengal 700106
Kolkata
WEST BENGAL |
9688907467
ezhilmathishanmugam37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of National institute of homoeopathy |
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 medicines |
Using the eligibility criteria and obtaining written informed consent participants will be included in the study. Patients will be administered individualised homoeopathic medicines based upon the totality of symptoms in homoeopathic dilution for a duration of six months. Dose and repetition will be decided as per requirement of the case on the basis of homoeopathic principles. Each enrolled case will be followed up monthly or as per need of the case up to 6 months. During the study, the in-vitro effectiveness of homoeopathic individualised medicines against microbes will also be checked. Outcome data will be assessed through UTI SIQ 8 scoring at baseline, 3 and 6 months. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having two or three UTIs in six months or three or more in a year or if symptoms that don’t disappear within 24 to 48 hours after treatment begins or if urinary tract infection that lasts longer than two weeks
Patients of both genders different socio economic status of all religions
Patients of age groups 10 to 60 years of age
Patient’s parents who are willing to give written informed consent and to participate in the study and give verbal children aged between 10 to 11 years and or written assent children aged between 12 to 17 years
Patients or parents or guardians of patients who can read or write or understand either English Hindi or Bengali languages |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Patient taking any antibiotics
Patients undergoing any other homeopathic medications
Patient having any psychiatric or life threatening illness severe systemic illness or immuno compromised state
Patients with any conditions requiring surgical interventions such as SOL malignancy or stone in PUJ or VUJ |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determination of the invitro effectiveness of the individualised homoeopathic medicines against inhibiting growth of the bacterial pathogens causing chronic urinary tract infections
Significant changes of UTI SIQ 8 score before and after treatment with individualised homoeopathic medicines for patients affected by chronic urinary tract infection |
Baseline 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of any correlation between clinical study and invitro bacterial inhibition |
Baseline 3 and 6 months |
|
|
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)
|
26/02/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Research question - is there any inhibition in the growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient Are individualised homoeopathic medicines effective in reducing the symptoms in patients of chronic urinary tract infections Null hypothesis is there is no significant change in growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient There is significant change in UTI SIQ 8 scoring in patients with chronic urinary tract infections when treated with individualised homoeopathic medicines Alternate hypothesis is there is significant change in growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient There is significant change in UTI SIQ 8 scoring in patients with chronic urinary tract infections when treated with individualised homoeopathic medicines Aim is to evaluate the effectiveness of individualised homoeopathic medicines against cultured strains of bacterial pathogens causing chronic urinary tract infections To assess the clinical effectiveness of individualised homoeopathic medicines in treating chronic urinary tract infections by determining the changes in symptom scoring of chronic urinary tract infections Primary objectives are to determine whether there is any inhibition in the growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient To determine the changes of UTI SIQ 8 score before and after treatment with individualised homoeopathic medicines for patients affected by chronic urinary tract infections To determine the correlation between changes in the symptoms of chronic urinary tract infections and changes in the growth of pathogens invitro after application of individualised homoeopathic medicine chosen for that particular patient It is a single arm interventional study conducted at the OPD setting of National Institute of Homoeopathy, Kolkata where each case will be taken in detail appropriate consent taken and then the patient will be enrolled. Appropriate statistical tools will be used and data analyzed at the end of the study. |