| CTRI Number |
CTRI/2024/02/062300 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in involuntary leakage of urine during stress in women in comparison to placebo |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic medicines in treatment of Stress urinary incontinence (SUI) in women : A double blind randomized placebo 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 Suraia Parveen |
| Designation |
Research Officer(H)/S-3 |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute For Homoeopathy, Kolkata. |
| Address |
Dr. Anjali Chatterjee Regional Research Institute (H), 50, Rajendra Chatterjee Road, Kolkata – 700035, West Bengal.
Kolkata
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research Officer(H)/S-3 |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute For Homoeopathy, Kolkata. |
| Address |
Dr. Anjali Chatterjee Regional Research Institute (H), 50, Rajendra Chatterjee Road, Kolkata – 700035, West Bengal.
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research Officer(H)/S-3 |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute For Homoeopathy, Kolkata. |
| Address |
Dr. Anjali Chatterjee Regional Research Institute (H), 50, Rajendra Chatterjee Road, Kolkata – 700035, West Bengal.
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy (CCRH), Ministry of AYUSH. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy (CCRH) |
| Address |
61-65, Institutional area, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmalaya Rath |
Dr D.P.R.Central Research Institute (H), |
Department Homoeopathy Division Clinical Research Room no 109
A-1, SECTOR 24,GAUTAMBUDH NAGAR, NOIDA-201301
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
drpadmalaya@gmail.com |
| Dr Suraia Parveen |
Dr. Anjali Chatterji Regional Research Institute |
Department Homoeopathy
Division Clinical Research
Room no 4
50, Rajendra Chatterji road, Kolkata
Kolkata
WEST BENGAL |
7001510319
drsuraiya2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
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 |
| Intervention |
Homoeopathic medicines |
Intervention is planned as administering indicated homoeopathic remedies in centesimal scale of potencies as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4-6 globules moistened with the indicated medicine, to be taken orally; dosage and repetition depending upon the individual requirement of the cases. Along with medicine, the patients will receive standard physiotherapy or pelvic exercises. Duration of therapy 6 months |
| Comparator Agent |
Placebo |
Placebo, indistinguishable from verum, thrice a day orally for 6 months. Along with placebo, the patients will receive standard physiotherapy or pelvic exercises. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 25-70 years
2. Female
3. Participants suffering from the symptoms of SUI having Stress scores ≥ 4 for SUI in QUID score.
4. Providing written informed consent to take part in the study
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating mother
2. Unwilling to take part and not giving consent to join the study
3. Women with continuous urinary leakage with current UI drug therapy with neurological disorder.
4. Presence of pelvic organ prolapsed (POP), stages III or IV
5. Patient with Spinal cord injury,
6. Bladder abnormalities (interstitial cystitis or bladder pain syndrome, bladder cancer, Renal calculi or Urinary stone)
7. Detrusor under activity
8. Urogenital infections ( UTI - Urinary tract infection, Bacterial cystitis, urethritis)
9. Advanced or uncontrolled Diabetes mellitus.
10. Other uncontrolled or life-threatening illness e.g. myocardial infarction, CVA (cerebro vascular accident) , Chronic Renal failure
11. Diagnosed cases of unstable mental or psychiatric illness
12. Non-ambulant patients.
13. Patients who are too sick for consultation
14. Substance abuse and or dependence
15. Self-reported immune-compromised state.
16. Undergoing homeopathic treatment for any chronic disease within two weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Individualized Homoeopathic Medicines (IHMs) in reducing symptom frequency or intensity of stress UI (with or without urge) by comparing the significant statistical differences in symptoms score in “The Questionnaire for Urinary Incontinence Diagnosis (QUID)†between Homoeopathic intervention and Placebo group. |
at base line and at every months of follow up for 6 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. To evaluate the effectiveness of IHMs on increasing symptom bother & greater impact on daily activities from UI symptoms by comparing the significant statistical changes in symptom scores in Incontinence Impact Questionnaire – Urinary Distress Inventory (UDI) & Urinary incontinence-specific quality of life (QOL) respectively.
3. To evaluate the quality of life (QoL) (physical, social, occupational & psychological) of patients suffering from SUI by comparing the significant statistical changes using Short Form 36 scores between HI & Placebo groups.
4. To ascertain & shortlist the most frequently indicated homoeopathic medicines in treatment of SUI. |
at baseline , every month for 6 months of treatment.
|
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 |
|
Date of First Enrollment (India)
|
22/02/2024 |
| 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="2"
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
|
A Multi-centre
Randomized Double Blind Placebo Controlled Clinical Trial of Individualized homoeopathy in women with Stress
urinary incontinence (SUI) symptoms will
be conducted at Dr Anjali Chatterji Regional Research Institute (H), Kolkata
and DDPR Central Research Institute (H), Noida. The women in the age group of
25 to 70 years having Stress urinary incontinence (SUI) symptoms will be studied. The study shall have
two arms viz. homoeopathic arm and placebo arm. Two
series of medicines shall be used. One will comprise of Individualized
Homoeopathic medicine in centesimal potencies manufactured by a licensed
homoeopathic pharmaceutical company approved by the Council, the other will
comprise of identical matching placebo. Standard Physiotherapy (Pelvic floor
exercise & others) will be applied on both arm by Physiotherapist as per
requirement. The main outcome measures (Primary) will be the assessment of SUI
symptoms utilizing ‘The Questionnaire for Urinary Incontinence Diagnosis (QUID ) score†The other outcome (secondary) Urinary incontinence-specific quality of
life (QOL) will be assessed using the “Urinary Distress
Inventory (UDI)†and Urinary Impact Questionnaire (UIQ) and overall
health-related QOL by Short Form -36.
On conclusion of the study the data obtained shall be
statistically analyzed with the help of a suitable statistical package to
evaluate the effectiveness of Individualized homoeopathy in management of
symptoms of SUI with improvement of Quality of life and the results shall be
disseminated to the medical fraternity. |