| CTRI Number |
CTRI/2022/09/045422 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homoeopathy in Attention Deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
Therapeutic Response of Individualized Homoeopathic Medicine in the Management of Attention Deficit Hyperactivity Disorder- An Exploratory Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarishi Manjul Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddh Nagar
UP
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8887515433 |
| Fax |
|
| Email |
dr.tarishimanjul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tarishi Manjul Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddh Nagar
UP
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8887515433 |
| Fax |
|
| Email |
dr.tarishimanjul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Chawla |
| Designation |
Assistant Professor |
| Affiliation |
Bakson Homoeopathic medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddh Nagar
UP
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
09971078406 |
| Fax |
|
| Email |
dr.mansiclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Office
Room NO G 22.
Ground Floor
Bakson Homoeopathic Medical College,
36B Knowledge Park- I
Greater Noida |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical Hospital |
| Address |
Room No G 22
Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddh Nagar
Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tarishi Manjul Singh |
National Institute for Empowerment of Person with Intellectual Disability (NIEPID) |
Outpatient Department (OPD)
Room No 8
Second Floor
C- 44/A, sector 40. Gautam Buddha Nagar Noida – 201310. U.P.
Gautam Buddha Nagar
UTTAR PRADESH |
8887515433
dr.tarishimanjul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College & Hospital |
Approved |
| National Institute for the Empowerment of Persons with Intellectual Disability |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Homoeopathic Medicines |
Homoeopathic Medicines
Gloubles form
Pill Size 30
Oral Route of administration
centesimal scale
Follow up every 4 weeks. Repetition of the dose according to the Follow up |
| Intervention |
Group B- Placebo |
Gloubles form
Pill Size 30
Oral Route of administration centesimal scale
Follow up every 4 weeks.
Repetition of placebo every 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who fit the criteria of ADHD according to the diagnostic criteria given
in DSM – V.
2. Age group 6 - 14 years will be taken for study
3. Sex: Both sexes are included.
|
|
| ExclusionCriteria |
| Details |
1. Subject with other psychiatric conditions like Down syndrome, Intellectual Disability etc.
2. Patients with a severe systemic illness like juvenile diabetes, suicidal tendency, child schizophrenia etc.
3. Children presenting with the concurrent convulsive disorder.
4. Children on psychotropic drugs: antidepressants, anti-anxiety medication, mood stabilizers, antipsychotics.
5. Children who are on Allopathic medicine for ADHD
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive changes on NICHQ VANDERBILT ASSESSMENT SCALE is expected |
Evaluation done at baseline, 4 weeks, 8 weeks till 6 months
12 Months study
5 months enrollment
6 months Follow up
1 month analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/09/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Exploratory study to be done to assess the role of Homoeopathic Medicines on Attention Deficit Hyperactivity Disorder. 66 sample size NICHQ Vanderbilt Assessment Scale will be used to assess the changes. |