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CTRI Number  CTRI/2024/11/076241 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Studying how a Homeopathic system of medicine helps in treating the children of 3-12 years with Attention Deficit Hyperactivity Disorder 
Scientific Title of Study   Assessment of Miasmatic approach in the attention deficit hyperactivity disorder in the age group of 3-12 years- An 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  Soibam Elora Devi 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth Deemed to be University, Homoeopathic Medical College and Hospital 
Address  Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Dept of Postgraduate and Research Centre Pune Bangalore Highway Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  8787641137  
Fax    
Email  kellysoibam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinodini VPatil 
Designation  Associate Professor Dept of Organon of Medicine 
Affiliation  Bharati Vidyapeeth Deemed to be University, Homoeopathic Medical College and Hospital 
Address  Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Dept of Postgraduate and Research Centre Pune Bangalore Highway Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9890127840  
Fax    
Email  vinodini.patil@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Soibam Elora Devi 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth Deemed to be University, Homoeopathic Medical College and Hospital 
Address  Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Dept of Postgraduate and Research Centre Pune Bangalore Highway Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  8787641137  
Fax    
Email  kellysoibam@gmail.com  
 
Source of Monetary or Material Support  
BVDU Homoeopathic Medical College, Dept of Postgraduate and Research Centre, Pune-Bangalore Highway, Pune-411043 
 
Primary Sponsor  
Name  Dr Soibam Elora Devi 
Address  Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Dept of Postgraduate and Research Centre Pune Bangalore Highway Pune 411043  
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 Soibam Elora Devi  Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital  Bharati Vidyapeeth (Deemed to Be University) Department of Organon of Medicine with Homoeopathic Philosophy, Organon of Medicine OPD, Pune-Satara Road, Dhankawadi ,Katraj, Pune-43
Pune
MAHARASHTRA 		 8787641137

kellysoibam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Potentized homoeopathic medicine  Potentized homoeopathic medicine in the form of pills or powder. Dose: Based on the symptom similarity will be prescribed in appropriate potency and doses based on the susceptibility of each individual case. Route of administration: oral. Total duration of the study:18 months 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients with hyperactivity, destructive tendency.
Patient fulfilling the diagnostic criteria of DSM 5.
Primary diagnosis of ADHD.
Patient opting for the homoeopathic treatment.
Patient complying for the regular follow ups.
Patient in the age group of 3-12 years.
All sexes.
 
 
ExclusionCriteria 
Details  Patient with Hearing and Speech defect.
Any medical irreversible pathological and systemic disease condition.
Any psychotic or neurologic condition (e.g., bipolar disorder, oppositional behavioral disorder, conduct disorder, schizophrenia but not including ADHD with common comorbidities such as internalizing, externalizing and learning disorders.)
4. Patients who have not filled the consent form.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the role of miasmatic background in the children of age 3-12 years with the ADHD.  The study duration will be of 18 months and 20 days with 6 months of follow up 
 
Secondary Outcome  
Outcome  TimePoints 
To study the role of homoeopathic medicines in the treatment of attention deficit hyperactivity disorder
 		 The study duration will be of 18 months and 20 days with 6 months of follow up 
To review the literature pertaining to the attention deficit hyperactivity disorder  The study duration will be of 18 months and 20 days with 6 months of follow up 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   Phase 3 
Date of First Enrollment (India)   18/11/2024 
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="6"
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 - NO
Brief Summary   This study is Single Blind Non-Randomized controlled trial to see the results of the predominant miasmatic background in the attention deficit hyperactivity disorder using Vanderbilt ADHD scale. The duration of the treatment will be of 18 months and will be done on 34 patients at Bharati Vidyapeeth medical foundation Homoeopathic Hospital OPD, IPD and various Rural and urban camps conducted by the hospital, Katraj and Periphery OPDs. The primary outcome will be assessed using the follow up of 20 days with 6 months duration to see the role of miasmatic background in the children of age 3-12 years with attention deficit hyperactivity disorder. The secondary outcome will be of to study the effectiveness of homeopathic medicines in the treatment of attention deficit hyperactivity disorder and review the literature pertaining to the attention deficit hyperactivity disorder. 
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