The purpose of this study is the evaluation of efficacy of adding acupuncture to methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents.This is a randomized-double blind trial that its inclusion criteria include:informed consent from participants and therir parents,10-18 years of age,ADHD diagnosis by 2 child psychitrists,not having comorbidities including mental retardation,epilepsy,pervasive developmental disorder,schizophrenia,manic episode,anxiety disorders,bipolar disorder,learning disorders of special skills and hyperactivity caused by organic disorders or drug reactions by clinical interview,being on treatment by methylphenidate(Ritalin) or Ritalin and clonidine and its exclusion criteria include: those who do not tolerate acupuncture,non-compliance and change in other treatments during study.The study sample size is 45 persons in each group and totally 90 persons.12 sessions of acupuncture is done for everyone in patient group (3 sessions weekly) and 12 sessions of sham acupuncture is done for everyone in control group.Before treatment and 3 weeks after acupuncture participants are tested with ADHD rating scale-IV and Continuous Performance Test by a blind evaluator and the results are compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091121852N1
Registration date:2016-11-27, 1395/09/07
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Mahsa Nahidi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 9383
Email address
nahidimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Study of effect of adding acupuncture to methylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
Public title
acupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:informed consent from participants and therir parents;10-18 years of age,ADHD diagnosis by 2 child psychitrists;not having comorbidities including mental retardation,epilepsy,pervasive developmental disorder,schizophrenia,manic episode,anxiety disorders,bipolar disorder,learning disorders of special skills and hyperactivity caused by organic disorders or drug reactions by clinical interview;being on treatment by
methylphenidate(Ritalin) or Ritalin and clonidine.
Exclusion criteria:those who do not tolerate acupuncture;non-compliance;change in other treatments during study
Age
From 10 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not 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 Sciences
before the intervention and 3 weeks after the intervention
Method of measurement
ADHD Rating Scale-IV questionnaire
2
Description
Continuous Performance Test score
Timepoint
before the intervention and 3 weeks after the intervention
Method of measurement
Continuous Performance Test
Secondary outcomes
empty
Intervention groups
1
Description
Patient group will receive acupuncture for 12 sessions(three 40 minute sessions weekly).
Category
Treatment - Other
2
Description
Control group will receive sham acupuncture for12 sessions(three 40 minute sessions weekly).In this group special needles are used that do not enter the skin and acupoints are different from the patinent group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Hospital Outpatient Clinics
Full name of responsible person
Mahsa Nahidi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Affairs of Mashhad University of Medical Sciences