Effect of treatment of attention deficit hyperactivity disorder (ADHD) with and without routine treatment of constipation on improvement of clinical symptoms in patients with functional constipation: a randomized clinical trial
To assess the effect of treatment of attention deficit hyperactivity disorder (ADHD) with and without routine treatment of constipation on improvement of clinical symptoms in patients with functional constipation
Design
This a randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with attention deficit hyperactivity disorder who will refer to Besat Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 4 to 12 years
Attention deficit hyperactivity disorder for at least 6 months
Functional constipation
Exclusion criteria:
Oppositional depressive disorder
Learning disorder
Intervention groups
Intervention group: Treatment of attention deficit hyperactivity disorder including Ritalin0.3 to 1 mg/kg 3 times per day for 3 to 5 days
Control group: Treatment of attention deficit hyperactivity disorder including Ritalin0.3 to 1 mg/kg 3 times per day for 3 to 5 days plus routine treatment constipation including powder Pidrolax 0.7 mg/kg twice a day for 3 to 5 days
Main outcome variables
Primary outcome: Assessing the constipation before intervention and one week after that thought history taking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N222
Registration date:2018-05-26, 1397/03/05
Registration timing:retrospective
Last update:2018-05-26, 1397/03/05
Update count:0
Registration date
2018-05-26, 1397/03/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment of attention deficit hyperactivity disorder (ADHD) with and without routine treatment of constipation on improvement of clinical symptoms in patients with functional constipation: a randomized clinical trial
Public title
Effect of treatment of attention deficit hyperactivity disorder (ADHD) with and without routine treatment of constipation on improvement of clinical symptoms in patients with functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 4 to 12 years
Attention deficit hyperactivity disorder for at least 6 months
Functional constipation
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.UMSHA.REC.1395.535
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Assessing the constipation
Timepoint
before intervention and one week after that
Method of measurement
Thought history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment of attention deficit hyperactivity disorder including Ritalin 0.3 to 1 mg/kg 3 times per day for 3 to 5 days
Category
Treatment - Drugs
2
Description
Control group: Treatment of attention deficit hyperactivity disorder including Ritalin 0.3 to 1 mg/kg 3 times per day for 3 to 5 days plus routine treatment constipation including powder Pidrolax 0.7 mg/kg twice a day for 3 to 5 days or Bisacodyl 5 mg per day for 3 to 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Alireza Momeni
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
dr.alireza2020@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Dr Alireza Momeni
Position
Resident of Pediatric
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
dr.alireza2020@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nasrollah Pezeshki
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
pezeshki61@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available