Evaluation of the effects of standardized hydroalcoholic extract of rosemary (Rosmarinus officinalis L.) capsule as adjunctive treatment in major depressive disorder
Evaluation of the effects of standardized hydroalcoholic extract of rosemary (Rosmarinus officinalis L.) capsule as adjunctive treatment in major depressive disorder
Design
This study is a randomized, double-blind, controlled clinical trial with a parallel group design of 44 patients.
Settings and conduct
Patients are selected from Kerman Baysat Clinic. Participants and physicians are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Outpatient with Major Depression Based on DSM-5 Criterion, 18-55 years old, depressed patient who has never been on medication and is a candidate for SSRI treatment.
ٍٍExclusion criteria:Pregnancy, lactation, having underlying medical or psychiatric illnesses, hypersensitivity reactions to rosemary, people at high risk of suicide, mental retardation - dependence on a variety of substances
Intervention groups
The treatment group receives one capsule daily (each capsule containing about 500 mg of extract) for 8 weeks and the control group receives the same placebo in terms of shape, color, and packaging with the same dose of the treatment group.
Main outcome variables
Anxiety and depression are measured using the Hospital Anxiety Depression Scale and Beck Depression Inventory second edition questionnaires at baseline, 4 weeks and 8 weeks later.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110310006026N11
Registration date:2019-11-07, 1398/08/16
Registration timing:prospective
Last update:2019-11-07, 1398/08/16
Update count:0
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of standardized hydroalcoholic extract of rosemary (Rosmarinus officinalis L.) capsule as adjunctive treatment in major depressive disorder
Public title
Evaluating the effects of rosemary capsule as adjunctive treatment in major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatient with Major Depression Based on DSM-5 Criterion, 18-55 years old, depressed patient who has never been on medication and is a candidate for SSRI treatment.
Exclusion criteria:
Pregnancy, lactation, having underlying medical or psychiatric illnesses, hypersensitivity reactions to rosemary, people at high risk of suicide, mental retardation - dependence on a variety of substances
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants are allocated to one of the two study groups in a 1:1 ratio. Allocation is by block randomization with a block size of four. A person (not involved in the trial) generates allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physician: rosemary and placebo capsules had the same shape, color and outer packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.KMU.REC.1398.359
Health conditions studied
1
Description of health condition studied
major depressive disorder
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study and ,the fourth and eight weeks after the beginning of the study