Condition category
Mental and Behavioural Disorders
Date applied
26/08/2004
Date assigned
31/08/2004
Last edited
09/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes