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CTRI Number  CTRI/2024/05/066943 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic medicine for Nocturnal Enuresis (Bed wetting) in children 
Scientific Title of Study   Role of Individualized homoeopathic medicine in management of nocturnal enuresis in children based on Dr Kents evaluation of symptomatology An open single arm interventional study 
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 Abhishek Sharma 
Designation  Post Graduate Trainee 
Affiliation  State National Homoeopathic Medical College And Hospital 
Address  Department of Organon of medicine and homoeopathic philosophy State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7895413990  
Fax    
Email  theabhisheksharma@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Vijay Pushkar 
Designation  Principal 
Affiliation  State Dr Brijkishore Homoeopathic Medical College And Hospital 
Address  State Dr Brijkishore Homoeopathic Medical College And Hospital Deokali Ayodhya Uttar Pradesh

Faizabad
UTTAR PRADESH
224001
India 
Phone  9415466529  
Fax    
Email  Vijay04pushkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Sharma 
Designation  Post Graduate Trainee 
Affiliation  State National Homoeopathic Medical College And Hospital 
Address  Department of Organon of medicine and homoeopathic philosophy State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7895413990  
Fax    
Email  theabhisheksharma@outlook.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh 
 
Primary Sponsor  
Name  Dr Abhishek Sharma 
Address  State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh 226010 
Type of Sponsor  Other [SELF] 
 
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 Abhishek Sharma   State National Homoeopathic Medical College And Hospital  Department of Organon of medicine and homoeopathic philosophy State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH 
7895413990

theabhisheksharma@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of State National Homoeopathic Medical College And Hospital  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  Homoeopathic Individualized Medicine  Individualized homoeopathic medicine will be prescribed after a detailed case history and repertorization with the help of reportory and potency of medicine will be determined as per individual case requirement.  
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  (1) Patients of age between 5 to 13.
(2) Both sexes are included.
(3) Diagnostic-criteria is based on clinical presentation.
(4) Improvement-criteria is based on NOCTURNAL ENURESIS SCORING SCALE
(5) Patient’s attendant given consent to participate.
 
 
ExclusionCriteria 
Details  (1) Patient of age above to 13 years.
(2) Patient diagnosed from CKD, DM & DI or any other disease which cause bed wetting.
(3) Children under the treatment of diuretics medicine.
(4) Children suffering from any congenital anomaly of urinary tract.
(5) Patient unwilling for inclusion in the study and those who are not able to come for follow-up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nocturnal Enuresis Scoring Scale  At baseline and after every 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nocturnal Enuresis Scoring Scale  At baseline and after every 15 days 
 
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   N/A 
Date of First Enrollment (India)   18/05/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  


Nocturnal Enuresis is a common and upsetting disorder that can significantly affect a child’s behaviour as well as their emotional and social lives. Parents experience more stress from it. Normal daily schedules and social activities, such as sleeping and going to school, can be disturbed. Additionally, it can lead to far more severe emotions and behaviors like, hopelessness, a lack of optimism, guilt and shame, humiliation, victimization, and a loss of self-worth.

Studies on homoeopathy have demonstrated effective treatment for nocturnal enuresis. Although there are numerous homoeopathic medications recommended in the literature for the treatment of nocturnal enuresis, there is a scarcity of research supporting these claims.

Therefore, the present study is undertaken to explore how Individualized homoeopathic medicine selected on the basis of Kent’s evaluation of symptomatology are useful in the treatment of nocturnal enuretic patient aged 5 to13 years.

Objectives of this study will be 

 (1)   To assess the significant reduction in episodes of bed-wetting before and after the administration of Individualized homoeopathic medicine by using Nocturnal  Enuresis  Scoring            Scale.

 (2)   To undestand the importance of Kent’s evaluation of symptoms in homoeopathic prescription.

    (3) To improve mental health of children by proper counselling.

   Individualized homoeopathic medicine will be prescribed after a detailed case history and determine the scores from nocturnal enuresis scoring scale and repertorization with the help

   of reportory and potency of medicine will be determined as per individual case requirement.

Each patient will be followed up every 15 days and final assessment will be done by using nocturnal enuresis scoring scale of pre and post treatment scores.

 
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