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CTRI Number  CTRI/2024/12/078091 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Homoeopathic medicine in the management of bed wetting in children 
Scientific Title of Study   Determining the Role of Homoeopathic medicine in the management of Nocturnal enuresis using ORIDL scale: Experimental Self controlled 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 PRADHNYA SHENDE 
Designation  PhD Scholar 
Affiliation  DR M L DHAWLE HOMOEOPATHIC INSTITUTE PALGHAR 
Address  DR M L Dhawale Memorial Homoeopathic Institute, Palghar, Boisar road ,Opposite S.T. Workshop , Palghar 401404 Maharashtra, India
PALGHAR DIST THANE
Thane
MAHARASHTRA
440030
India 
Phone  9890144520  
Fax    
Email  drpradnyammendhe@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C R Goda 
Designation  Professor and HOD Of Paediatric department 
Affiliation  Dr M.L.Dhawale Memorial Homoeopathic Institute,Palghar 
Address  Dr M.L.Dhawale Memorial Homoeopathic Institute,Palghar,Boisar Road,Palghar,Opposite ST Workshop Thane, Maharashtra 401404

Thane
MAHARASHTRA
401404
India 
Phone  9323690095  
Fax    
Email  sujchan18@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRADHNYA SHENDE 
Designation  Assistant Professor FMT 
Affiliation  DR M L DHAWLE HOMOEOPATHIC INSTITUTE PALGHAR DIST THANE 
Address  Dr M L Dhawale Homoeopathic Institute, Palghar- Boisar Road , opposite S.T. Workshop, District Palghar, Maharashtra, India
PALGHAR DIST THANE
Thane
MAHARASHTRA
401404
India 
Phone  9890144520  
Fax    
Email  drpradnyammendhe@gmail.com  
 
Source of Monetary or Material Support  
DR M L DHAWALE HOMOEOPATHIC MEDICAL INSTITUTE, Boisar road,Opposite ST Workshop, PALGHAR District Palghar, Maharashtra, India 401404 
 
Primary Sponsor  
Name  DR PRADHNYA SHENDE 
Address  DR M L Dhawale Homoeopathic Memorial Institute Opposite ST Workshop, Dist Palghar, 401404 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 PRADHNYA SHENDE  DR M L Dhawale Memorial Institute Palghar  Palghar , Boisar Road,Opposite ST Workshop,401404, Academic Building 2nd Floor,Paediatric Department room no 306 ,Dhawale Trust Hospital,Palghar,Ground Floor OPD No 111 Thane Maharashtra 401404
Thane
MAHARASHTRA 		 9890144520

drpradnyammendhe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR M L DHAWALE HOMOEOPATHIC MEDICAL INSTITUTE,PALGHAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic constitutional remedy based on simile similibus curanter of the individual  Indicated Homoeopathic Medicine will be prescribed for management of nocturnal enuresis based on individual constitution and susceptibility , dose will be given oral route for one year  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Informed consent given by the parents/guardians of children of both sexes in paediatric age group of 5-14 years of diagnosed cases of nocturnal enuresis 
 
ExclusionCriteria 
Details  1.Children less than 5 years and more than 14 years of age group.
2. patients on any other medication.
3.patients those are immunocompromised.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To study the effect of Homoeopathic remedy in improving the quality of life in nocturnal enuresis in paediatric age group
2) To Study the Prevalence of nocturnal enuresis in paediatric age group 5-14 years
3)To study the Gender prevalence of nocturnal enuresis of enrolled sample size.
 		 1) Duration of study is 18 months
2Time points for follow up of 15 days or as when required
3) Duration of each case: case will be managed unto the date of improvement or observed for a period of minimum 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1 to study prevalence of nocturnal enuresis in paediatric age group 5-14 years
2.improvement in ORIDL SCALE in case of nocturnal enuresis
3. posology for indicated medicines 		 follow up of each case will be after 15 days.
improvement or observed for a period of six months 
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   23/12/2024 
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="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 [drpradhnyammendhe@gmail.com].

  6. For how long will this data be available start date provided 02-01-2025 and end date provided 02-01-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study cases of nocturnal enuresis will be selected and treated with indicated  homoeopathic remedies by using ORIDL scale. Its the study to determine the  common group of   homoeopathic remedies in management of nocturnal enuresis .and study is done to determine the posology of commonly indicated medicine in homoeopathic management. 
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