Homoeopathy in involuntary leakage of urine during stress in women in comparison to placebo
- Conditions
- Health Condition 1: N393- Stress incontinence (female) (male)
- Registration Number
- CTRI/2024/02/062300
- Lead Sponsor
- Central Council for Research in Homoeopathy (CCRH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: at base line and at every months of follow up for 6 months of treatment.
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>4. To ascertain & shortlist the most frequently indicated homoeopathic medicines in treatment of SUI.Timepoint: at baseline , every month for 6 months of treatment. <br/ ><br> <br/ ><br>