| CTRI Number |
CTRI/2024/12/077960 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic intervention of Ginkgo biloba in the treatment of ADHD participants |
|
Scientific Title of Study
|
Evaluating The Effects Of Ginkgo Biloba In The Management Of Attention Deficit Hyperactivity Disorder In Children An Exploratory 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 |
Dr Vrishti Baghel |
| Designation |
PG scholar |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department Of Pediatrics
Ground Floor
Room Number 20
Bakson Homoeopathic Medical College and Hospital
36B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9009752908 |
| Fax |
|
| Email |
baghelvrishti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Gontiya |
| Designation |
Guide & Associate Professor |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Pediatrics
Ground Floor
Room no 20
Bakson Homeopathic Medical College & Hospital 36B Knowledge Park 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9999407479 |
| Fax |
|
| Email |
drritugontiya1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
HOD & Professor |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Paediatrics
Ground Floor
Room number 20
36B Bakson Homeopathic Medical College & Hospital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homeopathic Medical College & Hospital 36B Bakson Homeopathic Medical College & Hospital phase 1 Knowledge Park 1 Greater Noida
UP 201310
|
|
|
Primary Sponsor
|
| Name |
Bakson Medical college & hospital |
| Address |
Principal office
Ground Floor
G 22
36B Bakson Homeopathic Medical College & Hospital phase 1 Knowledge Park 1 Greater Noida
UP 201310
|
| Type of Sponsor |
Private medical college |
|
|
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 Vrishti Baghel |
Bakson Homeopathic Medical College & Hospital |
Out patient department
Ground floor
Room no.01
Bakson Homeopathic Medical College & Hospital
36 B Knowledge park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
9009752908
baghelvrishti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bakson Institutional committee |
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 |
Ginkgo biloba |
The oral route of administration in solid form (30 number globules size)of desired potency will be considered as 1 dose given after case taking repetition will be based on susceptibility and follow ups of participants at regular intervals of 1 month for an intervention period of 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Clinicaly diagnosed cases of ADHD.
Childrens from 3 to 17 years of age of both the sexes male and female.
Participants who are taking different types of therapies.
Participants willing to give assent or consent by the legal guardians
|
|
| ExclusionCriteria |
| Details |
Participants suffering with severe systemic illness or any immuno-compromised conditions, severe psychiatric illness, substance abuse and endocrine disorders.
Participants taking any form of treatment since last 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of the study will be assessed through changes in Conners parent rating scale
in ADHD childrens before and after our medicine
|
scale will be assessed at baseline 3 months 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="3"
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 is a single-blind clinical study using the predefined homoeopathic medicine (Ginkgo Biloba) in decimal potency in the management of ADHD, the primary outcome is to assess the efficacy of ginkgo biloba by using Conner’s parent rating scale at baseline, 3 months, 6 months. |