| CTRI Number |
CTRI/2025/11/097785 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the Effectiveness of Individualized Homeopathic Treatment for Urinary Incontinence Using the ICIQ-UI Scale. |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF INDIVIDUALIZED HOMEOPATHIC MEDICINE IN URINARY INCONTINENCE BY USING ICIQ-UI SCALE:A SINGLE BLIND RANDOMIZED PLACEBO CONTROL TRAIL. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrFarhana Mohammedzuber Mamji |
| Designation |
PG SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No 402 PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
Vadodara
GUJARAT
391760
India |
| Phone |
9737394260 |
| Fax |
|
| Email |
mamjifarhana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. GAURAV SHARMA |
| Designation |
BHMS MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
Vadodara
GUJARAT
391760
India |
| Phone |
9824372731 |
| Fax |
|
| Email |
gaurav.sharma18479@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR GAURAV SHARMA |
| Designation |
BHMS MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
Vadodara
GUJARAT
391760
India |
| Phone |
9824372731 |
| Fax |
|
| Email |
gaurav.sharma18479@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
Dr. Farhana Mohammedzuber Mamji |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,PARUL UNIVERSITY ,LIMDA WAGHODIA VADODARA GUJRAT 391760 |
| 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 |
| DrFarhana Mohammedzuber Mamji |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
Vadodara
GUJARAT |
9737394260
mamjifarhana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr.Alpesh Shah |
Approved |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE (Institutional Ethics Committee For Human Research)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R32||Unspecified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE WILL BE PRESCRIBED IN SELECTIVE POTENCY AS IN REQUIRED REPETATION FOR 15 DAYS OR WHEN REQUIRED |
| Comparator Agent |
PACEBO |
ONE GROUP WILL BE PRESCRIBED PLACEBO AND IT IS RANDOMIZED CONTROL TRAIL. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed Diagnosis of one of the following type of urinary incontinence : stress,urge or mixed urinary incontinence
2. All Socioeconomic Status
3. No current treatment for urinary incontinence
4.patient having consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patient using other medications or therapies
for urinary incontinence.
2. Pregnancy,lactating or postpartum cases in
women.
3. Patient with cognitive impairment.
4. Patient with bladder/pelvis abnormality like
urethral diverticulum,vesicovaginal fistula or
pelvic prolapse in female.
5. Patient suffering fromneurological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in urinary incontinence severity measured using ICIQ-UI Score.
Primary Outcome Description:
Mean change in the ICIQ-UI total score (range 0–21; higher score = greater severity) from baseline to 12 weeks. The questionnaire will be self-administered by participants and scored as per ICIQ guidelines. Comparison will be made between individualized homeopathic medicine and placebo. |
8Weeks to 12Weeks after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the efficacy of homeopathic individualized remedies and kegal exercise in cases of urinary incontinence by using ICIQ-UI Scale.
2.To assess the impact of Kegel exercise and placebo combination with kegel exerscise and homeopathic individualized remedies in urinary incontinence.
|
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
03/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The study is single blind,randomized,placebo controlled trail to assess the efficacy of individualized homeopathic medicine in urinary incontinence using ICIQ-UI Scale. The study will be conducted in 80 participant which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital ,Vadodara ,Gujrat, India.The study will be conducted in the time duration 1 year. |