| CTRI Number |
CTRI/2024/05/067328 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy Preventive Screening Process of Care Changes Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of homoeopathic medicines in Bedwetting in children |
|
Scientific Title of Study
|
A Prospective Clinical Study To Ascertain The Clinical Utility Of Homoeopathic Medicines In Cases Of Nocturnal Enuresis In Children With The Help Of NESS Tool |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alfaiz Kureshi |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Homoeopathic Materia Medica, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
GUJARAT
360002
India
Rajkot GUJARAT 360002 India |
| Phone |
9429797650 |
| Fax |
|
| Email |
alfaiz3499qureshi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Homoeopathic Materia Medica, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
GUJARAT
360002
India
Rajkot GUJARAT 360002 India |
| Phone |
9825885350 |
| Fax |
|
| Email |
rajesh.sanjarhmc@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Alfaiz Kureshi |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Homoeopathic Materia Medica, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
GUJARAT
360002
India
Rajkot GUJARAT 360002 India |
| Phone |
9429797650 |
| Fax |
|
| Email |
alfaiz3499qureshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot - 360002 |
|
|
Primary Sponsor
|
| Name |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE PARUL UNIVERSITY |
| Address |
Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot - 360002 |
| Type of Sponsor |
Private 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 Alfaiz Kureshi |
Sainath Homoeopathic Hospital, Rajkot Homoeopathic Medical College, Parul University |
Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot - 360002 Rajkot GUJARAT |
9429797650
alfaiz3499qureshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat |
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 |
INDIVIDUALIZED
HOMOEOPATHIC MEDICINE
|
Individualized homoeopathic
medicine. Mode of
Administration: Oral (sublingual)
Selection of potency, dose and
repetition : individualised
medicine will be presecribed in 30, 200, 1 M potency. selection
of dosage, potency and
repitition will be according to
susceptibility of patient and
principles of organon of
medicine
mode of administeration - oral
route
potency - 30, 200, 1m,
10m
frequency of repetition - every week
continuation till improvement is seen |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients within the age limit of 6-18 years will be included.
2. Both the sexes – Male and Female will be included.
3. Patients irrespective of their caste, religion and socio-economic condition.
4. Cases having psychological cause.
5. Cases having urinary infection with enuresis
6. Cases where worms infestation is ailment factor
7. Cases having reversible pathology |
|
| ExclusionCriteria |
| Details |
1. Patients below 6 years and above 18 years of age.
2. Cases having congenital anomalies and anatomical defects.
3. Patients with other systemic illness or serious and/or irreversible pathological conditions like disease of CNS, diabetes, spinal bifida etc.
4. Patients taking other therapeutic measures or any other diseases.
5. Mentally retarded child/ Cerebral palsy child |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of indicated homoeopathic medicines in cases of nocturnal enuresis in children |
it will be achieved within period of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The cases of AE will be analysed for result on the basis of following criterias –
 Significant Improvement – Patients with sense of well-being without complaints and no relapse of symptoms.
 Moderate Improvement – Patients who will have partial relief in symptoms will decrease in area and spread of AE.
 Mild Improvement – Patients who will have symptomatic amelioration without any change in area and spread of AE.
 Status Quo – Patients remain in as it is condition even after administration of similimum Homoeopathic Medicine.
|
there will be some improvement after prescribing
homoeopathic medicines after 9 months
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="0" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - 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 - Statistical Analysis Plan Response - Clinical Study Report
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alfaiz3499qureshi@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-06-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
o Nocturnal
Enuresis is very embaressing for any sufferers and in children as the age advances
it may produce a deep and very shameful impact to the patient.
o Nocturnal
enuresis in children is the 2nd most common disorder after allergic disease.[1]
The worldwide prevalence of enuresis among children aged 6-12 years is 1.4%- 28%.
The prevalence in India is 7.61%-16.3%. The prevalence is highest in children
aged 5-8 years & lowest in children aged 11-12 years. Nocturnal enuresis has
been reported in 18.4% of children with sleep problem.[2]
o In
conventional system of medicine, they usually give hormone like medication (desmopressin)
& the anti-depressant imipramine. Disadvantage of medication is that it usually
only works temporarily while you take it. There is also side effects of these
medication found in children such as headache, nausea, vomiting & dizziness.[3]
o As
the cause for nocturnal enuresis is moreover developemental or improper
training or psychogenic like
ü
Stressful
life events such as family conflicts, moving to a new place, starting a new
school or parental divorce can trigger bedwetting in some children. Anxiety
about these situations can lead to disrupted sleep patterns and increased
bladder activity during sleep.
ü
Emotional
disturbances such as fear, insecurity or unresolved emotional conflicts can
manifest as bedwetting. Children who feel anxious, insecure, or have low
self-esteem may be more prone to bedwetting.
ü
Excessive
pressure from parents to stay dry at night or punitive responses to bedwetting
can exacerbate the problem. This pressure can increase the child’s anxiety and
worsen their ability to control their bladder at night.
other modes of
treatment can’t offer much in addressing the Nocturnal Enuresis.
o Homeopathy
has surged in popularity within the medical community, offering efficient
solutions to completely eradicate diseases from the system, ensuring comfort.
Embracing a holistic approach, homoeopathy focuses on identifying and
addressing the underlying causes of ailments. It provides a dependable and
ethical mode of treatment. Wellness, as the integration of body, mind, and
spirit, underscores the understanding that our actions, thoughts, emotions, and
beliefs profoundly impact our well-being. Health, therefore, encompasses the
entirety of the individual rather than focusing solely on isolated parts or
organs. Homoeopathy, founded on this principle, constitutes a comprehensive
system of medicine that considers the entirety of an individual’s being;
facilitating the removal of root causes underlying diseases. By addressing the
cause, the symptoms naturally diminish.
o And
thus, homoeopathic remedies have shown effectiveness in alleviating enuresis
and reducing its likelihood of recurrence, all without the risk of side effects
which is commonly associated with allopathic treatment.
RESEARCH QUESTION:
o Whether
the patients suffering from Nocturnal Enuresis will get beneficial relief after
prescribing Homoeopathic Medicines?
HYPOTHESIS:
o Null
Hypothesis – There will be no improvement after prescribing homoeopathic
medicines
Alterntive Hyppothesis – There will be significant
improvemet after prescribing Homoeopathic medicines |