| CTRI Number |
CTRI/2024/03/064634 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic management of bed-wetting in children |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in the Management of Paediatric Enuresis: A Double-blind, Randomized, Placebo-controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-0109 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyan Chakraborty |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, 12 Gobinda khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8621967363 |
| Fax |
|
| Email |
kalyan21596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sangita Saha |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, 12 Gobinda khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433989717 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sangita Saha |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, 12 Gobinda khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433989717 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, 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 |
| Dr Kalyan Chakraborty |
D N De Homoeopathic Medical College and Hospital |
OPD Paediatrics (Room no. 2), OPD Medicine (Room no. 1), 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
8621967363
kalyan21596@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F980||Enuresis not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in
centesimal potencies (CH). 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 in 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/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good
Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies
and adjust the dosage in subsequent visits whenever required following the principles of classical
homoeopathy and such instances will be compared between groups. Patient will be provided with advice regarding toilet training and accessory
management as per Indian Academy of Paediatrics Guidelines for enuresis management. Duration of therapy four months. |
| Comparator Agent |
Placebos plus concomitant care |
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 in 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. The patients will receive advices on general management that consists of nonpharmacological treatment. Duration of therapy four months. Both medicines and placebos will be repacked in identical glass bottles and labelled with code, name of medicine, potency, and will be dispensed according to the random number list. The patients will be provided with advice regarding toilet training and accessory management as per Indian Academy of Paediatrics Guidelines for enuresis management. Duration of therapy: 4 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from Enuresis (ICD11 6C00) in a frequency of twice and above in a week since
last 3 months.
2. Patients scoring 9 or more in DVISS scale in the baseline.
3. Age 6-18 years.
4. Patients of both gender and transgender.
5. Participants having prior experience or knowledge of the treatment. e.g. primed to expect
‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated
through Patient Information Sheet. |
|
| ExclusionCriteria |
| Details |
1. Not providing written informed consent/ assent forms according to the age of participants as per
ICMR guidelines.
2. Patients having any anatomical and/or surgical changes leading to enuresis.
3. Patients who have taken any systemic antibiotics in the past one month.
4. Patients who are too sick for consultation.
5. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening
illness affecting quality of life or any organ failure.
6. Tobacco chewing and /or smoking, alcoholism and/or any form (s) of substance abuse and/or
dependence.
7. Self-reported immune-compromised state.
8. Already undergoing homoeopathic treatment for chronic disease within last 6 months.
9. Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DVISS (Dysfunctional Voiding and Incontinence Scoring System) |
Baseline, every month, up to 4 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2) |
Baseline, every month, up to 4 months |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 [kalyan21596@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Enuresis is a very common problem in childhood. When it persists beyond early childhood, it can be very stressful and distressing to the affected child as well as the family members. It results in severe psychosocial impact and also hampers the normal academic and recreational activities of children. Achieving continence as well as improving quality of life is therefore the main goal of treatment and that will lead to improvement of self-worth and self-confidence. Paediatric enuresis reveals an overall global prevalence ranging from 4 to 16% and prevalence in India is 7.61%–16.3%. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidences in support of homoeopathy in paediatric enuresis has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of enuresis in children. A double-blind Randomized(2:1) placebo-controlled trial will be conducted on 159 paediatric participants with complaints of enuresis. The aim of the trial is to find out the efficacy of IHM in the management of Paediatric enuresis over four months of intervention. The objectives are to detect the group differences in DVISS (Dysfunctional Voiding and Incontinence Scoring System) score (DVISS; primary objective), PEMQOL score, and MYMOP-2 score (secondary objective) between IHM and placebo in the management of paediatric enuresis every month over 4 months of intervention. ITT & PP analysis will be done to detect group differences using tests of unequal variance (e.g., Welch’s t-test) and ANOVA model respectively. The results will be published in scientific journals. |