| CTRI Number |
CTRI/2024/09/073185 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness Of Homoeopathic Medicine in Reducing Hyperactivity/Impulsivity in Children with Attention Deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In Reducing The Hyperactivity/Impulsivity In Children With Attention Deficit Hyperactivity Disorder |
| 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 Keerthana Balan P B |
| Designation |
Post Graduate Scholar,Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram(p.o),Kurichy
Kottayam
KERALA
686532
India |
| Phone |
7907431539 |
| Fax |
|
| Email |
drkeerthanabalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanaraj Kumar Rana |
| Designation |
Associate Professor,Research Officer/Scientist-II, Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram(p.o),Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanaraj Kumar Rana |
| Designation |
Associate Professor,Research Officer/Scientist-II, Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram(p.o),Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health, Kottayam, Kerala, India, Pin 686532 |
|
|
Primary Sponsor
|
| Name |
Dr Keerthana Balan P B |
| Address |
National Homoeopathy Research Institute in Mental Health,Sachivothamapuram(P.O),Kurichy,Kottayam,Kerala 686532,India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keerthana Balan P B |
National Homoeopathy Research Institute in Mental Health |
OPD,IPD,camps and peripheral units,Department of Psychiatry,National Homoeopathy Research Institute in Mental Health,Sachivothamapuram(P.O),Kurichy,686532
Kottayam
KERALA |
7907431539
drkeerthanabalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-National Homoeopathy Research Institute in Mental Health,Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 Medicines In Centesimal Scale |
Appropriate Individualized Homoeopathic Medicine shall be prescribed on a centesimal scale. Selected medicine will be started with 30 c potency and gradually increase as per the need of the case.The dose and frequency of repetition will be according to the severity of symptoms of the patient.Medicine will be given on monthly basis till the conclusion of the study. For acute complaints, current totality will be assessed and the most suitable remedy will be provided. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.children diagnosed with ADHD as per DSM-5 criteria.
2.children of any gender
3children in the age group of 3 to 12 years
4.SNAP-IV ADHD Hyperactive/Impulsive subscale parent score above 1.44 |
|
| ExclusionCriteria |
| Details |
1.children suffering from other major childhood psychiatric or medical conditions
2.children who are under conventional treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in hyperactivity /impulsivity symptoms in children with attention deficit hyperactivity disorder after the administration of individualized homoeopathic medicine In hyperactivity/impulsivity subset of the SNAP-IV teacher and parent rating scale |
Baseline ,at 3rd,6th,9th and at 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of overall symptom severity in children with attention deficit hyperactivity disorder after the administration of individualized homoeopathic medicine by using SNAP-IV teachers and parent rating scale |
Baseline,at 3rd,6th,9th and at 12 month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
05/09/2024 |
| 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
|
This study is a single-arm clinical interventional study to determine the effectiveness of Individualized Homoeopathic medicine in the management of Hyperactivity/Impulsivity symptoms of children with Attention Deficit Hyperactivity disorder that will be conducted in the OPD, IPD and peripheral unit of Department of Psychiatry at National Homoeopathy Institute in Mental Health, Kottayam. The primary outcome measure will be the reduction in the hyperactivity /impulsivity symptoms; assessed using the Hyperactivity /impulsivity subset of Swanson, Nolan, Phelam-IV teachers and parent rating scale (SNAP-IV). The secondary outcome will be the changes in overall ADHD symptom severity: assessed by using SNAP-IV teachers and parent rating scale. The study aims to make the effort to offer possibilities for future research on the effectiveness of individualized homoeopathic medicine in the management of hyperactivity /impulsivity symptoms of children with Attention Deficit Hyperactivity Disorder. |