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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [alfaiz3499qureshi@gmail.com].

  6. 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.

  7. 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 
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