| CTRI Number |
CTRI/2025/08/093774 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to See How Homeopathic Remedies Help in Managing Stress and Urge Urinary Incontinence, with Remedies Selected from Boericke’s Repertory |
|
Scientific Title of Study
|
Clinical Verification of Homoeopathic Remedies for Stress and
Urge Urinary Incontinence based On Boericke Repertory-A Randomized Controlled 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 Neela Dharshini |
| Designation |
Post Graduate |
| Affiliation |
Sarada Krishna Homeopathic Medical College and Hospital |
| Address |
Room no 301
Department of Homeopathic Repertory and Case Taking
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
7708257099 |
| Fax |
|
| Email |
neeladharshini99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Sankar A S |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homeopathic Medical College and Hospital |
| Address |
Room no 301
Department of Homeopathic Repertory and Case Taking
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Sankar A S |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homeopathic Medical College and Hospital |
| Address |
Room no 301
Department of Homeopathic Repertory and Case Taking
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Dissertation- Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 107
Ground Floor
Sarada Krishna Homoeopathic Medical College and Hospital
Kulasekharam
Kanniyakumari |
| 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 Neela Dharshini |
Sarada Krishna Homoeopathic Medical College and Hospital |
Room no 107
Ground Floor
Sarada Krishna Homoeopathic Medical College and Hospital
Kanyakumari
Kanniyakumari
TAMIL NADU |
7708257099
neeladharshini99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committe Sarada Krishna Homeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcarea phosphorica 6x |
Calcarea phosphorica 6x 2 pills in the morning and 2 pills at night daily with pelvic floor exercise |
| Intervention |
Individualised Homeopathic Medicine |
Individualised Homeopathic Medicine selected through Repertorisation from Boericke Repertory and is administered daily Orally 30th Potency 2 Globules after food at Morning once |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age groups from 30-45 years
Only females
Inclusion of patients with complaints of urinary incontinence |
|
| ExclusionCriteria |
| Details |
Patients with urinary tract infection other than incontinence of urine
Male patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare changes in frequency and amount of urination and severity of incontinence
using the RUIS scale between both groups over 8 weeks |
Reduction in intensity assessed in 15 days end of 2 months and also changes in frequency and quality of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify commonly used rubrics & remedies selected through Boerickes
Repertory in urge & stress incontinence cases |
To identify commonly used rubrics & remedies selected through Boerickes
Repertory in urge & stress incontinence cases in the total study period of 1.5 years with 2 months followup of each case |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="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
|
Urinary incontinence is the involuntary leakage of urine. The prevalence of urinary incontinence is likely underestimated, as many patients do not report their symptoms to healthcare providers for various reasons. It mostly affects women. The more times a woman has given birth, the more her risk of urinary incontinence goes up. Stress and urge incontinence is the most common form of urinary incontinence. Aim is to assess the clinical efficacy of individualized homoeopathic treatment, prescribed according to Boericke New manual of Homoeopathic Materia Medica with Repertory by William Boericke, in comparison to Calcarea phosphorica 6X in the management of urge and stress incontinence in parous females. Objectives are Compare changes in frequency and amount of urination and severity of incontinence using the RUIS scale between both groups over 8 weeks; to evaluate patient satisfaction and quality of life during the treatment period ,to identify commonly used rubrics and remedies selected through Boericke Repertory in urge and stress incontinence cases. Methodology is Random selection of 40 cases presenting with urinary incontinence conditions from the OPD,IPD and peripheral centres of Sarada Krishna Homoeopathic Medical College are taken. Detailed case taking is done and recorded in Sarada Krishna Homoeopathic Medical College standardized chronic case record format. Symptom analysis will be followed. Case will be repertorised with the totality of symptoms. Remedies will be prescribed based on Boericke New manual of Homoeopathic Materia Medica with Repertory by William Boericke. Follow up analysis, repetition, dosage will be done as per the direction of 5th and 6th edition of Organon of medicine. Follow up assessment will be done twice a month.Primary outcomes are effectiveness of individualized homoeopathic remedies in managing urge and stress incontinence in parous females, as assessed by changes in clinical symptoms; reduction frequency and amount of urination and improvement in quality of life is measured using validated scale such as RUIS scale, Improvement in quality of life, evaluated through patient-reported outcome measures.Secondary outcomes include Identification of frequently used rubrics in the treatment of urge and stress incontinence, as per Boericke New manual of Homoeopathic Materia Medica with Repertory, Analysis of the most commonly selected remedies based on repertorization results for urge and stress incontinence cases.
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