Aim: Possibility of use of Saffron as a new treatment for major depression and hyperlipidemia.
Study design: double blind randomized clinical trial.
Setting and conduct: This study will be carried out in a university clinic by a psychiatrist. 40 patients who fulfill the inclusion criteria will be included in the study. Patients will be randomly divided into two equal groups. Patient’s depression status will be evaluated three times: once at the beginning of the study, 4 and 6 week after treatment. Experimental group will receive 15mg saffron twice a day in capsules and the control group will receive starch in capsules twice a day for 6 weeks. Same amount of Fluoxetine will be given to both groups.
Inclusion criteria: diagnosed major depression; no lipid lowering medicine or depression treatment in last 6 months; informed consent; age between 18-55 years.
Exclusion criteria: history of suicide; presence of chronic disease such as metabolic disease and cancer; presence of ideas of suicide
Intervention: prescription of Fluoxetine and Saffron.
Main outcome measures: change in depression level and serum lipid profile.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110915334N1
Registration date:2013-12-25, 1392/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Sina Jelodar
Name of organization / entity
Shiraz university of medical science, student research committee
Country
Iran (Islamic Republic of)
Phone
+98 71 1624 8576
Email address
jelodars@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science, Student Research Committee
Expected recruitment start date
2012-12-04, 1391/09/14
Expected recruitment end date
2014-08-04, 1393/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of administration of Saffron extracts and Flouxetine on serum lipid profile in 40 patients with major depression.
Public title
Saffron, a herbal medicine for alteration of depression and serum lipids.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed major depression; no lipid lowering medicine or depression treatment in last 6 months; informed consent; age between 18-55 years.
Exclusion criteria: history of suicide; presence of chronic disease such as metabolic disease and cancer; presence of ideas of suicide.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee at shiraz medical university.
Street address
Ethic committee, Shiraz university of medical science, Zand street, Shiraz, Fars, Iran.
City
Shiraz
Postal code
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
ct-p-91-4913
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depressive status
Timepoint
at the beginning, 4th and 6th week of treatment
Method of measurement
Beck questionnaire
Secondary outcomes
1
Description
serum lipids
Timepoint
at the beginning and at the end of study
Method of measurement
laboratory
Intervention groups
1
Description
control: capsule filled with 15mg starch will be given twice a day as placebo and 20mg of Fluoxetine will be given once a day as the primary treatment.
Category
Treatment - Drugs
2
Description
Intervention: capsules containing 15mg saffron will be given twice a day and 20mg Fluoxetine will be given once a day as the primary treatment.