Contact information
Type
Scientific
Primary contact
Prof Shahin Akhondzadeh
ORCID ID
Contact details
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
+98 21 5412222
sakhond@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
555
Study information
Scientific title
Acronym
Saffron Project
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major depression
Intervention
In this double-blind, single-centre trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (10 mg three times a day [TDS]) (Group 1) and capsule of imipramine 100 mg/day (33.3 mg TDS) (Group 2) for a 6-week study.
Intervention type
Drug
Phase
Not Specified
Drug names
Crocus sativus L., imipramine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
01/02/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for major depression based on the structured clinical interview for DSM IV participated in the trial
2. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
01/02/2004
Locations
Countries of recruitment
Iran
Trial participating centre
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
Sponsor information
Organisation
Roozbeh Psychiatric Hospital (Iran)
Sponsor details
South Kargar
Tehran
13337
Iran
+98 21 5412222
sakhond@yahoo.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Tehran University of Medical Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15341662
Publication citations
-
Results
Akhondzadeh S, Fallah-Pour H, Afkham K, Jamshidi AH, Khalighi-Cigaroudi F, Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomized trial [ISRCTN45683816]., BMC Complement Altern Med, 2004, 4, 12, doi: 10.1186/1472-6882-4-12.