The aim of this randomized double blind study is comparison of antidepressant effect of Melissa officinallis and Lavandula angustifolia with fluoxetine. A total of sixty patients with major depressive disorder(mild to moderate) referring to psychiatry clinics are recruited and randomly assigned to receive either 20 mg of fluoxetine or 2 gr of Melissa officinallis and 2 gr of Lavandula angustifolia for 8 weeks. Severity of depression is assessed by the Hamilton Depression Rating Scale in weeks 0, 2, 4, and 8 after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061718126N1
Registration date:2015-06-04, 1394/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Mostafa Araj-Khodaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9528
Email address
araj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University, Vice Chancellor for Research
Expected recruitment start date
2015-05-23, 1394/03/02
Expected recruitment end date
2015-10-24, 1394/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melissa officinallis and Lavandula angustifolia products in treatment of depression.
Public title
Effect of Melissa Officinalis and lavandula angustifolia in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 - 65 years old; DSM-V criteria for major depressive disorder(mild to moderate); signed informed consent.
Exclusion criteria: positive history of other psychological disorders; consumption of alcohol or other addictive substances in last 2 weeks; serious medical disease; allergic reaction to medical herbs; positive history of suicidal attempt or suicidal intention; pregnancy; consumption of thyroid disorders drugs.
Age
From 18 years old to 65 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 for Medical Research, Shahed University
Street address
Shahed university-Opposite of Imam Khomeiny shrine-Qom freeway
City
Tehran
Postal code
Approval date
2015-03-15, 1393/12/24
Ethics committee reference number
41/226696
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline,2 , 4 and 8 weeks after starting the medication
Method of measurement
Hamilton rating scale for depression
Secondary outcomes
1
Description
Side Effects
Timepoint
0-2-4-8 weeks
Method of measurement
Clinical interview and physical examination and checklist
Intervention groups
1
Description
Melissa officinalis(each cap 500 mg)Usage: 2 cap every 12 hours for 8 weeks
Category
Treatment - Other
2
Description
Fluoxetin : (each cap 5 mg)
Usage: 2 cap every 12 hours for 8 weeks
Category
Treatment - Drugs
3
Description
Lavandula Angustifolia (each cap 500 mg)Usage: 2 cap every 12 hours for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry clinic
Full name of responsible person
Dr Ahmad Ali Noorbala
Street address
Unit 13- Building 280- Dolat
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Hasan Namdar
Street address
Shahed university-Opposite of Imam Khomeiny shrine-Qom freeway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Mostafa Araj Khodaei
Position
PhD student
Other areas of specialty/work
Street address
1471-between forsat and nosrat-North kargar-Engelab square
City
Tehran
Postal code
Phone
+98 21 6646 4320
Fax
+98 21 6646 4322
Email
mostafaa33@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate Professor of Pharmacology
Other areas of specialty/work
Street address
1471-between forsat and nosrat-North kargar-Engelab square
City
Tehran
Postal code
Phone
+98 21 6646 4320
Fax
+98 21 6646 4322
Email
naseri@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Mostafa Araj Khodaei
Position
PhD student
Other areas of specialty/work
Street address
1471-between forsat and nosrat-North kargar-Engelab square
City
Tehran
Postal code
Phone
+98 21 6646 4320
Fax
Email
m.aaraj@shahed.ac.ir; mostafaa33@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)