EFFECTIVENESS OF HOMOEOPATHIC MEDICINES ON URINARY INCONTINENCE

Phase 3

Not yet recruiting

• Conditions: Stress incontinence (female) (male), (2) ICD-10 Condition: N394||Other specified urinary incontinence,

• Registration Number: CTRI/2022/10/046919
• Lead Sponsor: DR VINITHA T

Brief Summary

Aim of the study :

To determine the effectiveness of individualised homoeopathic medicines in patients with Urinary Incontinence

Objectives of the study :

Primary Objective :

To find out the effectiveness of homoeopathic medicines in urinary incontinence disorder among women by using King’s Health Questionnaire

Hypothesis :

a..Null hypothesis :(H0)

There is no significant improvement in Urinary Incontinence patients after homoeopathic treatment.

b.Alternative hypothesis :(H1)

There is significant improvement in Urinary Incontinence patients after homoeopathic treatment.

Methods of Data Collection

1. A clinical Observational study will be conducted in the outpatient department of NHRIMH,Kottayam. Referral cases selected from peripheral camps also will  be included.

2. After filling screening form and after performing necessary Laboratory investigations including routine blood examination , urine analysis and Ultrasound Abdomen/Pelvis will be done , and then the cases, fitting in the inclusion criteria will be enrolled into the study.

3. Patient will be explained about the study in detail and written informed consent will be obtained.

4. Using standard case record format, cases will be recorded followed by formation of individual totality and repertorization will be done using appropriate repertory as per the need of the case. Final selection will be done after reference with Materia medica.

5. Each case will be follow up for one year after enrollment.

6. Depending on the susceptibility of the patient and severity of disease,medicine will be administered in various potencies and in appropriate doses according to the homoeopathic principles.

7. The Study will be conducted only after clearance from Institutional Review board , Ethical Committee , University and CTRI registration

Drop out Criteria

1. If patient is not reporting for 3 or more consecutive visits, even after telephonic follow ups, that patient will be dropped out from the study.

2. In case of any medical emergency, or complications, patient will be withdrawn from the study and treated as per the need or referred to higher centres for further management.

3. If there is any adverse reaction noted after administration of Homoeopathic medicine it will be reported to the Institutional pharmaco-vigilance department.

Outcome measurement :

Outcome of the treatment will be measured by assessing the symptomatic improvement and quality of life in the patients using King’s Health Questionnaires after the administration of homoeopathic medicine

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Females with Stress/Urge/Mixed Urinary Incontinence Symptoms 2.Females of age group 18 to 80 years 3.Symtpoms assessment by validated Questionnaires 4.All cases with Comorbidities like obesity ,diabetes and other metabolic conditions ,previous pelvic surgeries.

Exclusion Criteria

• 1.Cases with Acute Symptomatic Urinary tract infection excluded by Urine Analysis 2.
• Urinary tract congenital anomalies excluded by USG abdomen and Pelvis 3.Overflow Incontinence ,malignant pelvic neoplasms ,neuropsychiatric disorders 4.Pregnant and Lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out the effectiveness of homoeopathic medicines in urinary	6 Months enrollment with 1 year Follow up
incontinence disorder among women by using King’s Health Questionnaire	6 Months enrollment with 1 year Follow up

Trial Locations

Locations (1)

NATIONAL HOMOEOPATHIY RESEARCH INSTITUTE IN MENTAL HEALTH; 🇮🇳 Kottayam, KERALA, India

NATIONAL HOMOEOPATHIY RESEARCH INSTITUTE IN MENTAL HEALTH

🇮🇳Kottayam, KERALA, India

DR VINITHA T

Principal investigator

9047062259

rajinivinitha.rv@gmail.com