| CTRI Number |
CTRI/2025/12/099199 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF INDIVIDUALIZED HOMOEOPATHIC TREATMENT FOR URINARY INCONTINENCE IN POST MENOPAUSAL WOMEN |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN URINARY INCONTINENCE AMONG POST MENOPAUSAL WOMEN USING REVISED URINARY INCONTINENCE SCALE (RUIS) |
| 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 Indrajit |
| Designation |
PG Scholar |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second
Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum KARNATAKA 590010 India |
| Phone |
9096282054 |
| Fax |
|
| Email |
indrajitpatil171198@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothi Vijaykumar |
| Designation |
HOD and PG Guide |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second
Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum KARNATAKA 590010 India |
| Phone |
9964357653 |
| Fax |
|
| Email |
Jyothivijaykumar3@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothi Vijaykumar |
| Designation |
HOD and PG Guide |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second
Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum KARNATAKA 590010 India |
| Phone |
9964357653 |
| Fax |
|
| Email |
Jyothivijaykumar3@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr. Indrajit AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second
Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Indrajit |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Indrajit |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
AM Shaikh Homoeopathic Medical College, PG Research Centre And
Hospital, Department Of Homoeopathic Materia Medica, Ground Floor,
PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
590010 Belgaum KARNATAKA |
9096282054
indrajitpatil171198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL CLEARANCE FOR RESEARCH STUDY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The intervention involves the administration of an individualized homoeopathic remedy, to post menopausal women suffering from urinary incontinence; one dose in 30th potency as per requirement of the case. The treatment aims to reduce the frequency, intensity of urinary incontinence, as measured by the RUIS (Revised Urinary Incontinence Scale). The remedy will be
administered in oral pellet form, with the patient dissolving the pellets under the tongue. The dosage regimen
may involve taking a single dose or repeated doses depending on the severity and clinical judgment. The precise
dosage and frequency will be determined on an individual basis, typically tailored to the patients urinary incontinence pattern. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.All Post menopausal females of mild & moderate urinary incontinence according to 3 I Q (3 question questionnaire for diagnosis) will be included.
2.Cases will be included on the basis of history & physical examination.
3.Patients will be screened by USG & urine routine
|
|
| ExclusionCriteria |
| Details |
.Patients with Overflow urinary incontinence
2.Patients with Neurological Dysfunction like Multiple Sclerosis, Schizophrenia, spinal cord injury
3.Patients with Genitourinary Fistula.
4.Patients with Cardiac Pathology e.g.: Congestive Heart Failure, Ischemic heart disease, Cardiomyopathy.
5.Patients suffering with respiratory conditions that cause chronic coughing like COPD, Asthma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the baseline score on RUIS scale after giving individualized homoeopathic medicines |
Baseline (Day 0) and Last Follow up (Day 180) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="65" Sample Size from India="65"
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)
|
13/01/2026 |
| 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="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Urinary incontinence (UI) is a common and under-reported health problem among post-menopausal women, significantly affecting their physical, emotional, and social wellbeing. Due to hormonal changes, ageing, pelvic floor weakness, and other risk factors, the prevalence of UI increases after menopause. Conventional treatment options often have limitations, side effects, or low long-term compliance, leading many women to seek alternative therapies.
This study aims to evaluate the efficacy of individualized homoeopathic medicines in the management of urinary incontinence among post-menopausal women using the Revised Urinary Incontinence Scale (RUIS). A quasi-experimental single-arm interventional design will be used. Sixty-five eligible participants will be selected from the OPD/IPD and peripheral camps of A.M. Shaikh Homoeopathic Medical College, Belagavi. Each participant will receive individualized homoeopathic treatment based on totality of symptoms and will be followed monthly for six months.
The primary outcome measure is improvement in RUIS score before and after treatment. The study also aims to identify the most common subtype of urinary incontinence in this population. Data will be analyzed using appropriate statistical methods. The study intends to assess the role of individualized homoeopathic management as a complementary approach for urinary incontinence in post-menopausal women. |