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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  
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 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  
Status 
Not Applicable 
 
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.

 
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