| CTRI Number |
CTRI/2021/03/031807 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study With Homoeopathic Treatment In The Management Of Attention Deficit Hyperactivity Disorder in Children Aged 6- 15 years |
|
Scientific Title of Study
|
A Clinical Case Series With Homoeopathic Treatment In The Management Of Attention Deficit Hyperactivity Disorder In Children Aged 6- 15 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S SAHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Paediatrics
OPD Room No 5D
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Department of Paediatrics
OPD Room No 5D
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9940661304 |
| Fax |
|
| Email |
sahanasuresh95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
E RATHNASABAPATHI |
| Designation |
Professor and Head |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Paediatrics
OPD Room no 5D
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Department of Paediatrics
OPD Room no 5D
Vinayaka Nissions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9940661304 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S SAHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Paediatrics
OPD Room no 5D
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Department of Paediatrics
OPD Room no 5D
Vinayaka Nissions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9940661304 |
| Fax |
|
| Email |
sahanasuresh95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Salem 636308 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
S SAHANA |
| Address |
Department of Paediatrics
OPD Room no 5D
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Tamilnadu |
| 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 |
| S SAHANA |
Vinayaka Missions Homoeopathic Medical College and Hospital Salem |
Department of Paediatrics
OPD Room no 5D
NH 47 Sankari Main Road Seeragapadi Salem Tamilnadu
Salem
TAMIL NADU |
9940661304
sahanasuresh95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Homoeopathic medicines |
Homoeopathic medicines are selected based on individualization and the range of potency 30, 200, 1M, 10M will be used single dose of indicated remedy will be administered orally every month for a duration of 6 months considering disease state and vitality of patient |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children under - Multidisciplinary treatment.
Children fulfilling the criteria of the Swanson, Nolan and Pelham Parent and Teacher Rating Scale
(SNAP IV)
|
|
| ExclusionCriteria |
| Details |
Patients Who Have Oppositional defiant disorder, Intermittent explosive disorder, Specific learning disorder, Intellectual disability, Autism spectrum disorder, Reactive attachment disorder, Anxiety disorders, Depressive disorders, Bipolar disorder, Disruptive mood dysregulation disorder, Substance use disorders, Personality disease, Psychotic disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposed study will be useful in reducing the symptoms of Attention Deficit Hyperactivity in children aged 6-15 years. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that the proposed study will be useful in reducing the symptoms and improving quality of Attention Deficit Hyperactivity in children aged 6-15 years
The prognosis is done using the Swanson, Nolan And Pelham Parent and Teacher Rating Scale (SNAP IV) at the end of 6 months |
6 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Attention Deficit Hyperactivity Disorder is a
neurobehavioral disorder which is mostly seen from childhood prevailing more in
males than in females, there is markedly three types of classification seen in
ADHD, which includes Class I- Hyperactivity, impulsiveness and inattentiveness
(most common) Class II :
Hyperactivity and impulsiveness only Class
III: Mainly inattentiveness. Hence this study shows the efficacy of a
well choosen homoeopathic medicine for the treatment of ADHD between the age
group of 6 – 15 years, using the Swanson, Nolan and Pelham Teacher and Parent
Rating Scale IV
Study Design : A prospective clinical case series design
Sampling Type :
Non- Randomized Convenience sampling |