Comparison of Methylphenidate with the Combanition of Methylphenidate (MPH) and Crocus sativus (Saffron) in the treatment of children and adolescents with Attention-Deficit Hyperactivity Disorder (ADHD): a Randomized, Double Blind Clinical Trial
The main aim of this study is comparison of Methylphenidate (MPH) with the combanition of Methylphenidate and Crocus sativus (Saffron) in the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
Design
A randomized, double -blind, with parallel groups clinical trial. 90 patients with Attention-Deficit- Hyperactivity Disorder in two groups of 45 people in a phase III trial are assigned randomly.
Settings and conduct
Location is Fetros Comprehensive Health Center.90 patients are selected. 45 patients in Methylphenadiate group and 45 patients in combined Methylphenadiate and saffron group are assigned randomly. In this double-blind study, the psychiatrist and data analyser were kept blind to the treatment. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM), Lack of mental retardation, No use of Methylphenidate and Crocus sativus (saffron) before the study.
Exclusion criteria:Parent's dissatisfaction to participate in study, Psychiatric comorbidities (except for oppositional defiant disorder), Drug allergy.
Intervention groups
The first intervention group: group under treatment of Methylphenidate. The second intervention group: group under treatment of combined MPH and Saffron. The first group for 8 weeks uses10 -30 mg/d of Methylphenidate tablet (Created by Poorsina Pharmaceutical Company) depended on their weights daily . Also, the second group received previous prescription with Saffron capsules (Created by Knowledge-based company "Pouyesh darooye Sina") at a dose of 20–30 mg/d depending on their weight.
Main outcome variables
Symptoms of hyperactivity, symptoms of attention deficit, impulsivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190602043790N2
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Saba Hasanvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3324 2643
Email address
s.hasanvandi@alzahra.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Methylphenidate with the Combanition of Methylphenidate (MPH) and Crocus sativus (Saffron) in the treatment of children and adolescents with Attention-Deficit Hyperactivity Disorder (ADHD): a Randomized, Double Blind Clinical Trial
Public title
Comparison of Methylphenidate with the Combanition of Methylphenidate with Crocus sativus ( saffron) in the treatment of ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM)
Lack of mental retardation
No use of Methylphenidate and Crocus sativus (saffron) before the study
Exclusion criteria:
Parent's dissatisfaction to participate in study
Psychiatric comorbidities (except for oppositional defiant disorder)
Drug allergy
Age
From 6 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: Methylphenidate or a combination of Methylphenidate and Saffron. Even numbers are considered for the Methylphenidate group and odd numbers are for the Methylphenidate and Saffron group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment allocation was concealed from the psychiatrist and
the data analyser who rated patients by using successively numbered,
opaque, and sealed envelopes. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Kilometer 5 Road of Tehran-Khorram Abad, Lorestan University of Medical Sciences, Khorram Abad
City
Khorram Abad
Province
Lorestan
Postal code
44316-68151
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.LUMS.REC.1398.227
Health conditions studied
1
Description of health condition studied
Attention-Deficit Hyperactivity Disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
Hyperactivity symptoms
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated.
Method of measurement
Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV)
2
Description
Attention-Deficit symptoms
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated.
Method of measurement
Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV)
3
Description
Impulsivity
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated.
Method of measurement
Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:The first group was treated with (MPH): The first group for 8 weeks uses10 -30 mg/d of Methylphenidate tablet (Created by Poorsina Pharmaceutical Company) depended on their weights daily .
Category
Treatment - Drugs
2
Description
intervention group 2: The second group received 10 -30 mg/d of Methylphenidate tablet with Saffron capsules (Created by Knowledge-based company "Pouyesh darooye Sina") for 8 weeks at a dose of 20–30 mg/d depending on their weight daily.