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CTRI Number  CTRI/2025/09/094501 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathy for difficulties in holding urine in older adults 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in the treatment of urinary incontinence in geriatric people: A double-blind, randomized, placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1327-9818  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jagadish Ghosh 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept of Materia Medica, OPD Room no. PG-2, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  7478203150  
Fax    
Email  jagadishghosh688@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jagadish Ghosh 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept of Materia Medica, OPD Room no. PG-2, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  7478203150  
Fax    
Email  jagadishghosh688@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saima Shamim 
Designation  Reader 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept of Materia Medica, OPD Room no. PG-2, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, Govt of West Bengal, 12 Gobinda Khatick Road, Kolkata,700046, West Bengal 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road, Kolkata,700046, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagadish Ghosh  D N De Homoeopathic Medical College and Hospital  Dept. of Homoeopathic Materia Medica, OPD No- PG-2, 12 Gobinda Khatick Road, Kolkata, West Bengal, 700046
Kolkata
WEST BENGAL 		 7478203150

jagadishghosh688@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, D N De Homoeopathic Medical College and Hospital,12 Gobinda Khatick Road, Kolkata, WestBengal,700046  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R32||Unspecified urinary incontinence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking Placebo  This group will receive a placebo in conjunction with concomitant care. The placebo will have the same appearance as the active treatment. Each dose of the placebo will comprise 3-4 globules (number 40) of cane sugar, which will be moistened with rectified spirit and administered orally on a clean tongue while fasting; the dosage and frequency will be tailored to the individual needs of the participants. All materials will be sourced from a firm that adheres to Good Manufacturing Practice (GMP) standards. The follow-up period will last for six months. Both the active medications and placebos will be repackaged in identical glass containers, labelled with a code, the name of the medication, potency, and dispensed according to a random number list. Concomitant care: All the enrolled patients will receive advices on general management i.e., lifestyle modification including diet habits, restriction in drinking, weight losing for obese persons and pelvic floor muscle (PFM) exercise. The effectiveness of Kegel exercises relies on proper identification and isolation of the PFM, Technique: Empty your bladder, choose a comfortable position, often lying down or sitting initially, Squeeze and lift your PFM inward and upward, avoiding the use of abdominal, gluteal, or thigh muscles, Hold the contraction for 3-5 seconds. Relax completely for 3-5 seconds. Breathe normally throughout the exercise. Routine: Aim for 10 repetitions per set. Perform 2-3 sets per day. Gradually increase hold and relaxation times to 10 seconds as strength improves. Duration of care: 6 months. 
Intervention  Individualized Homoeopathic Medicines  This group will be provided with homoeopathic remedies along with concomitant care. Individualized homoeopathic medicines will be administered in centesimal potencies, as deemed suitable for each specific case or condition. Each dose on the centesimal scale will comprise 3-4 globules (number 40) of cane sugar, which will be moistened with the prescribed remedy (preserved in 90% v/v ethanol) and taken orally on a clean tongue while in empty stomach. The dosage and frequency will be tailored to the individual needs of the patients. They will be instructed to avoid handling the globules and to refrain from eating, drinking, smoking, or brushing their teeth for 30 minutes after ingestion. Patients will be encouraged to dissolve the globules in their mouths rather than swallowing them whole. A single, individualized remedy will be prescribed during each consultation, considering the totality of presenting symptoms, detailed clinical history, constitutional characteristics, miasmatic expressions, and repertorization using HOMPATH® software, when necessary, with appropriate reference to Materia Medica and consensus among three homoeopaths. All remedies will be sourced from a firm that adheres to Good Manufacturing Practice (GMP) standards. Concomitant care: All the enrolled patients will receive advices on general management i.e., lifestyle modification including diet habits, restriction in drinking, weight losing for obese persons and pelvic floor muscle (PFM) exercise. The effectiveness of Kegel exercises relies on proper identification and isolation of the PFM, Technique: Empty your bladder, choose a comfortable position, often lying down or sitting initially, Squeeze and lift your PFM inward and upward, avoiding the use of abdominal, gluteal, or thigh muscles, Hold the contraction for 3-5 seconds. Relax completely for 3-5 seconds. Breathe normally throughout the exercise. Routine: Aim for 10 repetitions per set. Perform 2-3 sets per day. Gradually increase hold and relaxation times to 10 seconds as strength improves. Duration of care: 6 months 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from urinary incontinence. ICD-11 code MF50.2 Urinary incontinence. Leakage of urine with or without control.
2.Age 60 – 75 years.
3.Participants of either sex or transgender.
4.Literate patients ability to read English, Hindi and or Bengali. Illiterate patient will be interviewed by the investigators maintaining
adequate privacy to fill up the scales questionnaires. 
 
ExclusionCriteria 
Details  1.Not willing to provide with written informed consent of voluntary participation.
2.Patients having neurological conditions, such as known multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury.
3.Patient who has been dealing with urinary symptoms with several modern medication in the past one month or any plan to have surgical treatment during the study.
4.Participants will be excluded if they had uterine prolapsed grade 3 or 4, vesicovaginal fistula; and any severe cardio-vascular diseases, uncontrolled diabetics.
5.Patient will be excluded if they had urinary tract infections, in urine microscopy - the presence above of 10 leukocytes per mm3 of uncentrifuged urine or 10 leukocytes per hpf of the centrifuged sample, in a clinically suspected UTI. Patients with haematuria recurrent and persistent, proteinuria.
6.Patients with BHP who require intervention beyond conservative management.e.g., surgical or invasive procedures. Patient with serum prostate specific antigen, PSA more than 10 nmol per ml.
7.Vulnerable population – unconscious, too sick for consultation or ambulatory, differently abled, terminally ill patients, mentally incompetent people etc.
8.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
9.Self-reported immune-compromised state, and already undergoing homoeopathic treatment for chronic disease within last 4 weeks.
10.Patient under tobacco chewing and or smoking, alcoholism and or any other forms of substance abuse and or dependence. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)  Baseline, and every month , upto 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life Assessment Questionnaire Concerning Urinary Incontinence (Contilife)  Baseline, and every month, up to 6 months 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   29/09/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jagadishghosh688@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Urinary incontinence (UI), defined as the involuntary loss of urine, is a significant health concern in the geriatric population. It not only impairs physical well- being but also leads to emotional distress, social withdrawal, and reduced quality of life. According to the statistical data from the National Association for Incontinence 200 million people were affected with urinary incontinence Worldwide . The prevalence of urinary incontinence in India ranges from 11.6 to 25.5% in rural tribal region  Current treatment approaches include pelvic floor exercises, bladder training, anticholinergic medications, and surgical interventions. However, many elderly patients either cannot tolerate these treatments or experience limited benefit due to adverse drug reactions such as xerostomia, constipation, and mental confusion or the treatment might result in worsening of underlying comorbidities.  Despite strong indications of individualized homoeopathic medicine in treatment of geriatric urinary incontinence in different homoeopathic literatures, the translations of those to the language of EBM is deficient. To fill up this gap this trial is undertaken. That is why the current work is aimed the effects of IHMs in centesimal scale through a double- blind, randomized (2:1), placebo-controlled, trial design ICIQ-UI-SF questionnaire for evaluation in UI in geriatric people after six months of intervention. Group differences will be detected using appropriate statistical tests. The results will be published in scientific journals. 
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