This is a double blinded, randomized, clinical trial, the aim of this study is evaluating the efficacy of Lavender as an adjuvant therapy along with methylphenidate on the treatment of children with attention deficit hyperactivity disorder (ADHD). Inclusion criteria: Patients with ADHD, age between 6 to 12 years. exclusion criteria: The patients with severe complications; People who do not have the consent to participate in the study; do not follow up. The total sample size is 44 and patients are randomly divided into two parallel groups as intervention and placebo groups. Also the randomization is doing with a randomization software. The intervention group is under treatment with methylphenidate and lavender and the placebo group is under treatment with methylphenidate. After 8 weeks, the outcomes of treatment are assessed using a ADHD Rating Scale-IV. Also the doctors and patients are blinded about study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091612782N18
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, School of Medicine, Isfahan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender medicine as a supplementary drug in the treatment of children with attention deficit hyperactivity disorder
Public title
The effect of lavender on the treatment of children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with attention deficit hyperactivity disorder (ADHD), age between 6 to 12 years. exclusion criteria: The patients with severe complications; People who do not have the consent to participate in the study; do not follow up.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUI.REC.1395.30295
Health conditions studied
1
Description of health condition studied
Attention-Deficit/Hyperactivity Disorder(ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Recovery rate
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
ADHD Rating Scale-IV
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients under treatment with methylphenidate tablet and lavender
Category
Treatment - Drugs
2
Description
Control group: Patients under treatment with methylphenidate tablet and placebo (starch and lactose content)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Fereshteh Shakibaei
Street address
Khorshid Hospital, Isfahan, Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Shakibaei
Position
Psychologist/ Associate professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3265 1574
Fax
Email
shakibaei@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Mehdi Kahkeshani
Position
General practitioner
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 938 068 6777
Fax
Email
mehdikahkesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences.
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for research/Master of Science
Other areas of specialty/work
Street address
Research office , Al-Zahra hospital, Al-zahra street, Isfahan, Iran
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)