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CTRI Number  CTRI/2024/11/076161 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 29/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Management of Hyperactivity in Attention deficit hyperactivity disorder of Children 
Scientific Title of Study   A clinical study on the homoeopathic management of hyperactivity in adhd diagnosed children 
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 P chandra sekaran 
Designation  PG scholar 
Affiliation  White memorial homoeo medical and hospital 
Address  Department of paediatrics White memorial homoeo medical college and hospital attoor veeyanoor

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9965712628  
Fax    
Email  dr.chandrudsalem@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Judin stephenson 
Designation  Associate professor  
Affiliation  White memorial homoeo medical and hospital 
Address  White memorial homoeo medical college and hospital attoor veeyanoor

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9538484284  
Fax    
Email  judzon3535@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P chandra sekaran 
Designation  PG scholar 
Affiliation  White memorial homoeo medical and hospital 
Address  Department of paediatrics White memorial homoeo medical college and hospital attoor veeyanoor

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9965712628  
Fax    
Email  dr.chandrudsalem@gmail.com  
 
Source of Monetary or Material Support  
White memorial homoeo medical college and hospital 
 
Primary Sponsor  
Name  Dr P chandra sekaran 
Address  White memorial homoeo medical college and hospital attoor veyanoor  
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 P Chandra sekaran   white memorial homoeo medical college and hospital  department of paediatrics White memorial homoeo medical college and hospitalattoor veeyanoor
Kanniyakumari
TAMIL NADU 		 09965712628

dr.chandrudsalem@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic medicine  medicated globules placebo once in fiften days  
Comparator Agent  Nil  Not applicable 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children of both sexes are included.
Children meeting the diagnostic criteria of Vanderbilt scale
 
 
ExclusionCriteria 
Details  • Patients below the age of 8 and above the age of 17.
• If a child is under treatment for any other major chronic illnesses.
• Children having congenital abnormalities.
• Patients with less than 1 follow-up.
• Children suffering from any other neurological hyper behavioral disorder other than ADHD.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Vanderbilt parent-teacher rating scale  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
nil  not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/11/2024 
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="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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  all the data will be provided through email dr.chandrudsalem@gmail

  6. For how long will this data be available start date provided 10-03-2027 and end date provided 10-03-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
A CLINICAL STUDY ON THE HOMOEOPATHIC MANAGEMENT OF HYPERACTIVITY IN ADHD DIAGNOSED CHILDREN
                      

             Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopment disorders of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors or be overly active.Homoeopathy is found to be effective in treating ADHD. The rubric ADHD is well mentioned in repertory, like complete repertory by Roger van Zandvoort’s and Homeopathy medical repertory by Robin Murphy.The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is abpsychologival assessment toolthat helps identy Attention Deficit Hyperactivity Disorder in children and adolescents.

 
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