Assessment of efficacy of Livergol tablets on ADHD symptoms
Design
Randomized Phase 2 clinical trial, on 40 patients, for randomization the www.random.org website was utilized.
Settings and conduct
Forty patients with attention deficit hyperactivity disorder referred to the children's psychiatric clinic of Imam Khomeini Hospital will be randomly divided into two groups. Both groups will receive standard treatment (Ritalin). The intervention group will receive Livergel 70 mg tablets daily for 60 days, and the control group will receive a placebo tablet once a day for 60 days. Connors questionnaire will be taken at the beginning and end of the study. Patients and therapists will be blinded to the assignment group. Medicine tablets and placebo tablets are prepared in the same package and marked with a unique code.
Community Verified icon
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 6-15 years old
Receiving written informed consent from patients
Diagnosis of ADHD is based on K_SADS by the Psychiatrist
No other psychiatric disorders
Lack of mental retardation
Not having a history of heart disease
Not having history of seizure
No drug allergy history
Exclusion criteria:
Children with other psychiatric disorders
Children with an allergy or previous side effects to Livergol
Intervention groups
Intervention group: patients will receive Ritalin and one tablet of livergol 70 mg daily for 60 days.
Control group: patients will receive Ritalin and one placebo tablet daily for 60 days.
Main outcome variables
the Conners ADHD rating scales
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N22
Registration date:2024-01-17, 1402/10/27
Registration timing:prospective
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Livergol in children with attention deficit hyperactivity disorder
Public title
efficacy evaluation of livergol in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 6-15 years old
receiving written informed consent from patients
diagnosis of ADHD is based on K_SADS by the Psychiatrist
Exclusion criteria:
children with other psychiatric disorders
children with an allergy or previous side effects to Livergol
Drug allergies
History of seizures
Pregnancy
Lactation
Age
From 6 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
At the start of the study and after 60 days the Conners ADHD rating scale will be used
Randomization (investigator's opinion)
Randomized
Randomization description
two groups of 20 patients were made using simple randomization method, based on Random sequence Generator via www.random.org website. For random allocation concealment, the method of opaque sealed envelopes with random sequence was used. Patients were allocated in one of two groups based on their entry sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and Psychiatric will be blind about allocation
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of islamic Azad university of pharmaceutical sciences
Street address
No 99, the first of yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۵۶۴۶۶
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.IAU.PS.REC.1402.054
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 Conners ADHD rating scales
Timepoint
At the entry and day 60
Method of measurement
the Conners ADHD rating scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will receive Ritalin and one tablet of livergol 70 mg daily for 60 days
Category
Treatment - Drugs
2
Description
Control group: patients will receive Ritalin and one placebo tablet daily for 60 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Mahla Tajabadi pour
Street address
At the end of Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Building of Islamic abad university of medical branch,Gol Yakh ave, Pa barja st, Shariari st.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2264 0599
Email
mparsania@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal Ave, Shariati st.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 2151
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Efat panah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Tehran University of Medical Sciences,Enghelab avenue.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2264 0051
Email
m.effatpanah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahla Tajabadi pour
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, The first of Yakhchal Ave, Shariati st. Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
0098 2264 2151
Email
mahla.taj98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available