Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomised trial

ISRCTN ISRCTN45683816
DOI https://doi.org/10.1186/ISRCTN45683816
Secondary identifying numbers 555
Submission date
26/08/2004
Registration date
31/08/2004
Last edited
09/08/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Shahin Akhondzadeh
Scientific

Roozbeh Psychiatric Hospital
Tehran
13337
Iran

Phone +98 21 5412222
Email sakhond@yahoo.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymSaffron Project
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMajor depression
InterventionIn 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Crocus sativus L., imipramine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date01/02/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment01/02/2004

Locations

Countries of recruitment

  • Iran

Study participating centre

Roozbeh Psychiatric Hospital
Tehran
13337
Iran

Sponsor information

Roozbeh Psychiatric Hospital (Iran)
Hospital/treatment centre

South Kargar
Tehran
13337
Iran

Phone +98 21 5412222
Email sakhond@yahoo.com
ROR logo "ROR" https://ror.org/019mzt973

Funders

Funder type

University/education

Tehran University of Medical Sciences (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 02/09/2004 Yes No