The aim of the present study is to evaluate the efficacy ofsaffron on ADHD in adults through a double-blind, randomized, controlled trial
Design
Randomized, double-blind, placebo controlled study
Settings and conduct
The study will be conducted among patients attending Roozbeh Hospital-Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of ADHD based on DSM-5; age between 20-60 years old. Exclusion criteria: chronic medical disease including seizure, cardiovascular disease, CVA and organic brain disease; substance abuse or dependence during past six months;nursing or pregnant patients; history of tic disorder; receiving of any psychotropics drugs during past two weeks; mental retardation ; history of suicide attempt, psychosis or aggressiveness; receiving psychotropic drugs; receiving psycho-stimulants or atomoxetine during past three months; bipolar disorder.
Intervention groups
Intervention group: capsule saffron 15 mg BID plus ritaline (methylphenidate) 30 mg per day for 6 weeks.
Control group: capsule placebo plus tab. ritaline 30 mg per day fo 6 weeks.
Main outcome variables
Severity of ADHD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N111
Registration date:2018-07-25, 1397/05/03
Registration timing:prospective
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2020-08-04, 1399/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron (crocus sativus) for attention deficit hyperactivity disorder in adults: a double blind and placebo controlled trial
Public title
saffron for attention deficit hyperactivity disorder in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD based on DSM-5
Age between 20-60 years old
Exclusion criteria:
Chronic medical disease including seizure, cardiovascular disease, CVA and organic brain disease
Substance abuse or dependence during past six months
Nursing or pregnant patients
History of tic disorder
Receiving of any psychotropics drugs during past two weeks,
Intellectual disability
History of suicide attempt, psychosis or aggressiveness
Receiving psycho-stimulants or atomoxetine during past three months
Bipolar disorder
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random Permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome evaluators will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.TUMS.VCR.REC.1397.259
Health conditions studied
1
Description of health condition studied
Disturbance of activity and attention
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Severity of ADHD
Timepoint
Baseline (before treatment) and weeks: 3 and 6 after treatment
Method of measurement
By adult ADHD Self-Report Scale and Conners Adult ADHD Rating Scales–Self-Report-screening version
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule saffron 15 mg BID plus Tab. ritaline ( methylphenidate) 30 mg per day for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Capsule placebo plus tab. ritaline ( methylphenidate) 30 mg per day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qhods St., Keshvarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
Msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be distributed through final report
When the data will become available and for how long
from 2021 to 2026
To whom data/document is available
En academic researchers
Under which criteria data/document could be used
All users should cite the source of data
From where data/document is obtainable
prof Shahin Akhondzadeh
What processes are involved for a request to access data/document