Study of effectiveness of alcoholic extract of Melissa officinalis on attention deficit hyperactivity disorder(ADHD) in children
Design
Two Side Blinded Randomised Trial
Settings and conduct
The location was Dr.Iraj Vosough, Parastar 1.2, Mashhad. Children from 6 to 15 with attention deficit hyperactivity disorder (ADHD) were chosen by specialists. This was a double blinded clinical trial. The content of capsules were unknown to both the doctor and patients, just pharmacist knew which group was drug or placebo. Capsules were given under name of group A and group B. Alcoholic extract of Melissa officinalis with a dose of 160 mg twice daily for 8 weeks was given to one group and placebo to another group under the same condition.
Participants/Inclusion and exclusion criteria
1.ِِDignosis of attention deficit hyperactivity disorder(ADHD) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition(DSM-V)
2.children aged from 6 to 15 years old
3.Filling the consent form
Intervention groups
Patients were randomly divided into two groups. Both groups were given capsules with the same appearance. One group was treated with alcoholic extract of Melissa officinalis with a dose of 160 mg twice daily for 8 weeks and placebo was given to the control group twice daily for 8 weeks.
Main outcome variables
Attention Deficit Hyperactivity Disorder (ADHD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190330043139N1
Registration date:2020-05-01, 1399/02/12
Registration timing:retrospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Pooria Vosouq
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 6373
Email address
v.pooria@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Melissa officinalis extract on the treatment of children with attention deficit hyperactivity disorder
Public title
The effect of Melissa officinalis on the treatment of children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6-15 years old
Diagnosis of Attention deficit hyperactivity disorder(ADHD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-V)
Filling the consent form
Exclusion criteria:
Age
From 6 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The study is double blinded, the form of medication and placebo is the same and neither the patients nor the experimenters know who is receiving a particular treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, the doctor, experimenter and analisor have been kept blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Pharmacy Campus, Mashhad Medical University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.556
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
Patients with Attention deficit hyperactivity disorder (ADHD)
Timepoint
Before starting the study and at 0, 4, and 8 weeks after starting treatment