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A clinical trial to compare the effects of curcumin with placebo on Attention-Deficit/Hyperactivity Disorder (ADHD) patients undergoing Ritalin treatment

Protocol summary

Summary
Objective: To compare the effects of curcumin with placebo on Attention-Deficit/Hyperactivity Disorder (ADHD) patients undergoing Ritalin treatment. Design: A double blind block randomized clinical trial. Study population: Attention-Deficit/Hyperactivity Disorder (ADHD) patients. Inclusion criteria: Aged between 7 and 15 years; diagnosis Attention-Deficit/Hyperactivity Disorder (ADHD) based on DSM-V-TR criteria; lack of mental retardation (MR), epilepsy, pervasive developmental disorder, schizophrenia, mania episode, anxiety disorders, bipolar disorder, special ability and learning disorders, and hyperactivity disorder due to organic brain syndrome (OBS) or drug reactions. Exclusion criteria: Liver and renal failure; thyroid disorder; allergy to curcumin; chronic inflammatory diseases; use of anti-inflammatory and antioxidant drugs. Sample size: 70 cases. Study intervention: The control group, children and teenagers with Attention-Deficit/Hyperactivity Disorder (ADHD) undergoing Ritalin treatment (0.1-3 mg) received 80 mg of placebo (similar components of curcumin capsules) twice a day. The intervention group, children and teenagers with Attention-Deficit/Hyperactivity Disorder (ADHD) undergoing Ritalin treatment (0.1-3 mg) received 80 mg of curcumin (Sina Drug) twice a day. Study outcome: Evaluation and comparison the effectiveness of clinical outcomes including learn, impulsivity, anxiety, hyperactivity and conduct disorder (CD) score base on questionnaire in intervention and control groups before, 4 and 8 weeks after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050433810N1
Registration date: 2017-05-28, 1396/03/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Marzea Rangian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38823255
Email address
mohararif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
A clinical trial to compare the effects of curcumin with placebo on Attention-Deficit/Hyperactivity Disorder (ADHD) patients undergoing Ritalin treatment
Public title
The effects of curcumin on Attention-Deficit/Hyperactivity Disorder (ADHD) patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 7 and 15 years; diagnosis Attention-Deficit/Hyperactivity Disorder (ADHD) based on DSM-V-TR criteria; lack of mental retardation (MR), epilepsy, pervasive developmental disorder, schizophrenia, mania episode, anxiety disorders, bipolar disorder, special ability and learning disorders, and hyperactivity disorder due to organic brain syndrome (OBS) or drug reactions. Exclusion criteria: Liver and renal failure; thyroid disorder; allergy to curcumin; chronic inflammatory diseases; use of anti-inflammatory and antioxidant drugs.
Age
From 7 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-11-18, 1394/08/27
Ethics committee reference number
IR.MUMS.fm.REC.1395.452

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
Evaluation the effectiveness of clinical outcomes including learn, impulsivity, anxiety, hyperactivity and conduct disorder (CD) score
Timepoint
before, 4 and 8 weeks after intervention
Method of measurement
Base on questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Children and teenagers with Attention-Deficit/Hyperactivity Disorder (ADHD) undergoing Ritalin treatment (0.1-3 mg) received 80 mg of placebo (similar components of curcumin capsules) twice a day.
Category
Treatment - Drugs

2

Description
Intervention group: Children and teenagers with Attention-Deficit/Hyperactivity Disorder (ADHD) undergoing Ritalin treatment (0.1-3 mg) received 80 mg of curcumin (Sina Drug) twice a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Marzea
Street address
Ranghian
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzea Ranghian
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
rangianm931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzea Ranghian
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
rangianm931@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzea Ranghian
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
rangianm931@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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