| CTRI Number |
CTRI/2022/04/041931 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for involuntary urination in old aged people |
|
Scientific Title of Study
|
Individualized homoeopathic medicines in treatment of urinary incontinence in geriatric people: A double-blind, randomized, placebo-controlled pilot trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1276-9881 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Gunin |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homeopathic philosophy, 12, Gobinda Khatick Road,Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7044094135 |
| Fax |
|
| Email |
amitgunin31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homeopathic philosophy, 12, Gobinda Khatick Road,Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
ganguly.subhasish@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homeopathic philosophy, 12, Gobinda Khatick Road,Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
ganguly.subhasish@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatik Road,Tangra, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatik Road,Tangra, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Amit Gunin |
D N De Homoeopathic Medical College & Hospital |
Department of Organon of Medicine and Homeopathic philosophy, room no. PG 1 OPD, 12, Gobinda Khatick Road,Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL |
7044094135
amitgunin31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of D N De Homoeopathic Medical College & Hospital |
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 |
| Comparator Agent |
Identical-looking placebos |
This group will receive identical looking placebos along with advice on general management. Each dose will consist of 4 cane sugar
globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition were maintained depending upon the individual requirement of the cases. All sundry items will be procured from a GMP certified firm. Both medicines and placebos will be re-packed in identical glass bottles and labelled
with code, name of medicine, potency, and will be dispensed according to the random
number list. All the enrolled patients will receive advice on general management i.e., lifestyle modification including diet habits, restriction in drinking,
weight losing for obese persons and pelvic floor muscle exercise. Duration of care: 6 months. |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering the individualized homeopathic medicines in centesimal potencies. Each dose will consist of 4 cane sugar globules no. 40 moistened with
the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual
requirement of the cases. Patients will be advised to refrain from handling the
globules or from eating, drinking, smoking or brushing teeth within 30 minutes of
taking the globules and will be asked to suck the globules rather than simply
swallowing those. Single individualized medicine will be prescribed on each occasion
taking into account presenting symptom totality, clinical history details,
constitutional features, miasmatic expressions, repertorization using HOMPATH
and RADAR software when required with due consultation of Materia Medica and due consensus among three homeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) - certified firm. All the enrolled patients will receive advice on general
management i.e., lifestyle modification including diet habits, restriction in drinking, weight losing for obese persons and pelvic floor muscle exercise. Duration of therapy: six months. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients suffering from urinary incontinence
(ICD-10 code R32 in geriatric people) since
last 3 months
b) Leakage of urine with or without control
c) Age 60 – 75 years
d) Patients of either sex
e) Literate patients; ability to read English
and/or Bengali
f) Providing written informed consent |
|
| ExclusionCriteria |
| Details |
a) Patients having neurological conditions, such
as known multiple sclerosis, clinically
significant peripheral neuropathy or spinal
cord injury.
b) Patient who has been dealing with urinary
symptoms with several modern medication in the
past one month or any plan to have surgical
treatment during the study.
c) Participants will be excluded if they had
uterine prolapsed grade 3 or 4, vesicovaginal
fistula; and any severe cardio-vascular
diseases, uncontrolled diabetics.
d) Patient will be excluded if they had urinary
tract infections (UTI), in urine microscopy -
the presence above of 10 leukocytes/mm3 of
uncentrifuged urine or 10 leukocytes/hpf of the
centrifuged sample, in a clinically suspected
UTI.Patient with serum prostate specific
antigen (PSA) > 10 nmol/ml.
e) Vulnerable population – unconscious, too sick
for consultation or ambulatory, differently
abled, terminally ill patients, mentally
incompetent people etc.
f) Diagnosed cases of unstable mental or
psychiatric illness or other uncontrolled
or life-threatening illness affecting quality
of life or any organ failure.
g) Self-reported immune-compromised state, and
already undergoing homoeopathic treatment for
chronic disease within last 4 weeks.
h) Patient under tobacco chewing and/or smoking,
alcoholism and/or any other form(s) of
substance abuse and/or dependence. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
International Consultation on Incontinence Questionnaire-Urinary
Incontinence Short Form (ICIQ-UI-SF) for incontinence of geriatric people. |
At baseline, every month, up to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Scale (QOLS) |
At baseline, every month, up to 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/04/2022 |
| Date of Study Completion (India) |
30/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amitgunin31@gmail.com].
- For how long will this data be available start date provided 01-11-2023 and end date provided 31-10-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Urinary incontinence (UI) is an inability to regulate the physical, physiological, or functional factors involved in the process of urination that leads to an involuntary loss of urine. According to the International Association of Urinary Incontinence, any involuntary leakage of urine is called UI. The highest prevalence of UI in older adult women was reported in Asia as 45.1%. Though homeopathy is one of the popular therapies in UI, research evidence is infrequent and inconclusive. A six-month, double-blind, randomized, placebo-controlled trial on 60 geriatric people with UI was conducted at D. N. De Homoeopathic Medical College and Hospital to identify the differences between individualized homeopathic medicines (IHMs; n = 30) and identical-looking placebos (n = 30) in the mutual context of concomitant care, e.g., lifestyle modifications including dietary habits, restriction in drinking, weight loss for obese persons, and pelvic floor muscle exercises. The primary outcome measure was the International Consultation on Incontinence Questionnaire – Urinary Incontinence – Short Form (ICIQ-UI-SF); the secondary outcome measure was the Quality-of-Life Scale (QOLS) – all measured at monthly intervals, up to 6 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences and effect sizes. Two groups were comparable at baseline. After 6 months of intervention, group differences were statistically significant in ICIQ-UI-SF (P = 0.002). The secondary outcome could not demonstrate any statistical significance, either in the total score (P = 0.086) or in other subscales, except recreation (P = 0.002). Twenty-nine different remedies were prescribed – Sulphur, Thuja occidentalis, and Causticum were the most frequently indicated ones. Thus, IHMs produced promising results in comparison with placebos in managing UI in geriatric people. Independent replication is required to confirm the findings. |