| CTRI Number |
CTRI/2024/03/063763 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Management In The Treatment Of Nocturnal Enuresis in Children |
|
Scientific Title of Study
|
A clinical study to assess the efficacy of plantago major in the management of nocturnal enuresis in paediatric age group |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraja kumar |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of
Paediatrics Opd Room 5D Vinayaka Missions Homoeopathic
Medical College And Hospital Nh 47 Sankari Main Road
Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8939465655 |
| Fax |
|
| Email |
neerajakumar27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KR Binisha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of
Paediatrics Opd Room 5D Vinayaka Missions Homoeopathic
Medical College And Hospital Nh 47 Sankari Main Road
Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8072095009 |
| Fax |
|
| Email |
krbpaediatrician@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KR Binisha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of
Paediatrics Opd Room 5D Vinayaka Missions Homoeopathic
Medical College And Hospital Nh 47 Sankari Main Road
Seeragapadi
TAMIL NADU
636308
India |
| Phone |
8072095009 |
| Fax |
|
| Email |
krbpaediatrician@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Vinayaka Missions Homoeopathic Medical College And Hospital Nh47 Sankari Main
Road Seeragapadi Salem Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Neeraja Kumar |
| Address |
Department Of
Paediatrics Opd Room 5D Vinayaka Missions Homoeopathic
Medical College And Hospital Nh 47 Sankari Main Road
Seeragapadi |
| 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 Neeraja Kumar |
Vinayaka Missions Homoeopathic Medical College And Hospital |
Department Of
Paediatrics Opd Room
No 5D Nh47 Sankari
Main Road
Seeragapadi Salem
Tamilnadu
Salem
TAMIL NADU |
08939465655
neerajakumar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee vinayaka missions kirupananda variyar medical college and hospital salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy Remedy |
Homoeopathic medicines are
selected based on
individualization of the patient.
Based on the susceptibility of
the patient the dose is selected.
Medicine is administered via
oral route. Follow up is taken
once in a month.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group above 5-12 years
Children, both male and female.
Children fulfilling the criteria of Nocturnal enuresis based on DSM 5 307.6 and Dysfunctional Voiding Scoring System (DVSS).
|
|
| ExclusionCriteria |
| Details |
Children with any added renal pathology, congenital malformation, ADHD, other behaviour disorders.
Children with type I Diabetes mellitus, Diabetes insipidus,
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dysfunctional voiding scoring scale (DVSS) |
At the baseline and the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that proposed study
Will be useful in reducing the
Symptoms severity of nocturnal enuresis using the medicine plantago major in paediatric age group
|
At the baseline & the end of the study |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The prevalence in India is 7.61%–16.3%.
The prevalence is highest in children aged 5–8 years (and 6–8 years) and lowest
in children aged 11–12 years (8–10 years). In general, prevalence of nocturnal
enuresis is higher among male children than female children. The worldwide
prevalence of enuresis among children aged 6–12 years is 1.4%–28%. In traditional medicine, tincture
of Plantago major was used in wound healing and in Homoeopathy
it is frequently prescribed for tooth and ear neuralgia. The efficiency of Plantago major in treating nocturnal enuresis has been
noted in Homoeopathy literary Books such as Materia medica, the Homoeopathic Pharmacopeia of India,
and Repertory; nevertheless, there is a paucity of Clinical reproving, which
highlights the need for further research. An exploratory Clinical study is
carried out taking into account the active principle, phytochemical property, and symptoms gathered
during drug proving regarding Nocturnal Enuresis. |