The effect of barij deprex capsule containing Echium amoenum L and Hypericum perforatum dry extracts on mild to moderate Depression and comparison with fluoxetine
Objectives: The aim of this study was to evaluate the efficacy of Barij Deprex capsule as an antidepressant in the treatment of mild to moderate depression .
Design: A randomized, double-blind, single central clinical trial, in the 8-week period.
Major Inclusion and Exclusion criteria: 60 patients 18-55 years old who referred to Kashan Karegarnejad Hospital with mild to moderate depression based on the Hamilton scale and clinical interview based on DSM-IV-TR criteria. Pregnancy and lactation; allergy to herbs in study; A cognitive disorder in the past year; History of bipolar disorder and other disorders Axis I(According to the SCID-I interview); Use of psychoactive medicines in the last 2 weeks; Severe medical conditions; Use of psychoactive substances; Patients with suicidal thoughts; History or use of vitamin supplements in the last 2 months are exclusion criteria.
Intervention: group 1: barij deprex capsules(350 mg), BID. Group 2: fluoxetine capsules(20 mg) , BID.
Main outcome variables: The severity of depression assessed by the Hamilton questionnaire and common side effect at the beginning, the fourth and eighth week of the study recorded then will be compared between the two groups and beginning of the study. Every two weeks,continue study, use medicine, the possible exclusion criteria and side effects are being investigated by telephone and the results are recorded in the questionnaire .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082612438N24
Registration date:2017-09-26, 1396/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal plants
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of barij deprex capsule containing Echium amoenum L and Hypericum perforatum dry extracts on mild to moderate Depression and comparison with fluoxetine
Public title
The effect of barij deprex capsule on Depressive symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-55 years old; patients with mild to moderate depression based on the Hamilton scale and clinical interview based on DSM-IV-TRcriteria
Exclusion criteria: Pregnancy and lactation; allergy to herbs in study; A cognitive disorder in the past year; History of bipolar disorder and other disorders
Axis I(According to the SCID-I interview); Use of psychoactive drugs in the last 2 weeks; Severe medical conditions; Use of psychoactive substances; Patients with suicidal thoughts; History or use of vitamin supplements in the last 2 months; Psychotic disorders
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
Postal code
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.kaums.rec.1396.46
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
f32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
severity of depression
Timepoint
beginning, four and eight weeks after the start of the study