| CTRI Number |
CTRI/2022/10/046919 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECTIVENESS OF HOMOEOPATHIC MEDICINES ON URINARY INCONTINENCE |
|
Scientific Title of Study
|
THE EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHIC
MEDICINE ON SYMPTOMATIC IMPROVEMENT AND QUALITY OF LIFE
IN WOMEN WITH URINARY INCONTINENCE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VINITHA T |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
National homoeopathic Research Institute in Mental Health |
| Address |
Department of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9047062259 |
| Fax |
|
| Email |
rajinivinitha.rv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S G S CHAKRAVARTHY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National homoeopathic Research Institute in Mental Health |
| Address |
Department of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
|
| Email |
sgschakravarthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S G S CHAKRAVARTHY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National homoeopathic Research Institute in Mental Health |
| Address |
Department of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
|
| Email |
sgschakravarthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kurichy,Kottayam |
|
|
Primary Sponsor
|
| Name |
DR VINITHA T |
| Address |
Department of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Kurichy
Kottayam |
| 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 |
| DR VINITHA T |
NATIONAL HOMOEOPATHIY RESEARCH INSTITUTE IN MENTAL HEALTH |
DEPARTMENT OF PRACTICE OF MEDICINE
NATIONAL HOMOEOPATHIY RESEARCH INSTITUTE IN MENTAL HEALTH
KURICHY
KOTTAYAM
Kottayam
KERALA |
9047062259
rajinivinitha.rv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), (2) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Individualized homoeopathic
medicines prescribed.
Route of Administration-Oral.
Dose-The selected medicine
would be prescribed start with
30,200,and higher potencies.
During the period of study ,the potency would be raised
sequentially as per the need of the case, in pursuance with the homoeopathic principles. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. 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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the effectiveness of homoeopathic medicines in urinary
incontinence disorder among women by using King’s Health Questionnaire |
6 Months enrollment with 1 year Follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |