The aim of the study is to determine the effect of ginko biloba on the symptoms of attention deficit hyperactivity disorder including sleep quality, nutrition quality, growth rate and academic performance.
Design
A randomized clinical trial with a control group and a parallel group, a single blind phase 3 will be conducted on 30 patients with ADHD in two groups of 15 people. For randomization, the rand function of Excel software will be used.
Settings and conduct
study will be conducted in the Besat Hospital in Hamadan on children aged 5 to 15 with ADHD disorder. patients will be randomly assigned to intervention and control groups Before the intervention, both groups will be evaluated with Connors questionnaire in terms of symptoms of ADHD. Both groups will receive treatment and usual care for one month, the intervention group will receive 3 gr ginko biloba drugs orally in addition to the usual treatment and care. At the end of one 1month, both groups will be checked again for symptoms of ADHD with Connors questionnaire, person who evaluate patients at end of study will be blind of the groups (single blind).
Participants/Inclusion and exclusion criteria
The participants are 5-15 year old patients with attention deficit hyperactivity disorder. Conditions for not entering the study include patients with neurological or organic disorders and patients on a special diet
Intervention groups
The first group of patients with attention deficit hyperactivity disorder will receive 3 grams of ginko biloba medicine daily for one month at the same time as usual treatments.
The second group of patients with ADHD will receive only the usual treatments, without ginko biloba medicine for one month.
Main outcome variables
The main outcome of the study is the changes in sleep quality, nutrition quality, growth rate, academic performance and cognitive status.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N31
Registration date:2023-10-08, 1402/07/16
Registration timing:prospective
Last update:2023-10-08, 1402/07/16
Update count:0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Ginko biloba on attention deficit hyperactivity disorder (ADHD) symptoms in children aged 5 to 15 years
Public title
Investigating the effect of Ginko biloba on attention deficit hyperactivity disorder symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5 to 15 years
Normal IQ
Exclusion criteria:
patients with neurological or organic disorder
Patients on a special diet
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We made 30 cards and write letter I on 15 for Intervention and on the other 15 letter C for the Control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter ( I or C) patients will be assigned to Intervention or Control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as single blind; In this way, the person who evaluating the outcome of the treatment will be blind about the treatment regimen
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.UMSHA.REC.1402.248
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
The outcome of the study includes changes in symptoms of ADHD including sleep quality, nutrition quality, growth rate, academic performance, cognitive status.
Timepoint
Before treatment and one month after treatment
Method of measurement
Variables with the 26-question questionnaire of Connors, which contains questions about sleep quality, nutrition quality, growth rate, academic performance, and cognitive status.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In addition to the usual treatment and care, this group will receive 3 grams of ginkgo biloba medicine daily for one month.
Category
Treatment - Drugs
2
Description
Control group: The control group will only receive usual care without receiving Ginkgo biloba medicine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Afshin Fayazi
Street address
همدان، بلوار شهید بهشتی، بیمارستان بعثت
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
Besat@Umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
افشین فیاضی
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Nedica School, Shahid Fahmide Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
009898138380572
Email
afshin_fay@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave,
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From March 2021
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
To improve patients treatment and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document