In this study that aimed to compare the efficacy of venlafaxine and lavender in the treatment of depression in patients without psychotic view, 120 patients with major depression without psychotic view referring to Psychiatric Clinic of Shahrekord University of Medical Sciences were randomly divided into three groups: venlafaxine, venlafaxine and lavender, venlafaxine and placebo groups. Patients in the control group received 37.5 mg of venlafaxine daily for 6 weeks , in the placebo groupthey received daily 37.5 mg of venlafaxine and every 12 hours one placebo T-Bag (peppermint) and the case group received daily
37.5 mg of venlafaxine and every 12 hours one T-Bag of lavender. Prior to the intervention, three weeks after the intervention and in the end of intervention, the patients were followed up and side effects, symptoms of depression and suicide risk assessed were recorded. In this study, the data were collected using questionnaire including demographic data, drug side effects and Hamilton Anxiety Depression Scale .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604116480N13
Registration date:2016-05-14, 1395/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellory for research and technology of Shahrekord University Of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of venlafaxine alone and venlafaxine with lavender in the treatment of patients with depression
Public title
Comparison of the effects of lavender and venlafaxine in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients referring to psychiatric clinic of Shahrekord University of Medical Sciences; depression diagnosed by a psychiatrist for the first time. Exclusion criteria: being sensitive to lavender; history of previous use of antidepressants or antidepressant properties of lavender or plants; patients with psychosis and diabetes.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University Of Medical Sciences
Street address
Shahrekord University Of Medical Sciences, Kashani Blvd
City
Shahrekord
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1824
Health conditions studied
1
Description of health condition studied
Depression without psychotic symptoms
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
depression
Timepoint
Before the intervention, three weeks after the start of intervention and six weeks after the intervention
Method of measurement
Hamilton Depression and Anxiety Inventory
2
Description
Anxiety
Timepoint
Before the intervention, three weeks after the start of intervention and six weeks after the intervention
Method of measurement
Hamilton Depression and Anxiety Inventory
Secondary outcomes
1
Description
drug side effects
Timepoint
3 and 6 weeks after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
In Placebo group, treatment includes venlafaxine 37.5 mg daily routine and oneT-Bag placebo (peppermint) every 12 hours (1/5 g)
Category
Placebo
2
Description
In the case group, treatment includes venlafaxine 37.5 mg daily routine every 12 hours one lavender teabag (1/5 g)
Category
Treatment - Drugs
3
Description
Routine treatment, daily 37.5 mg of venlafaxine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Doctor Masoud Nikfarjam
Street address
Psychiatry Department, Hajar Hospital, Parastar Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord, Medical Sciences University Of
Full name of responsible person
Doctor Kamal Solati
Street address
Vice Chancellory for research, Shahrekord University Of Medical Sciences, Kashani Blvd
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord, Medical Sciences University Of
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
Hajar Hospital
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry Department, Hajar Hospital, Parastar Street
City
Shahrekord
Postal code
Phone
+98 38 3334 9509
Fax
+98 33349509
Email
nikmas140@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hajar Hospital
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry Department, Hajar Hospital, Parastar Street
City
Shahrekord
Postal code
Phone
+98 38 3334 9509
Fax
+98 33349509
Email
nikmas140@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hajar Hospital
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Psychiatrist
Other areas of specialty/work
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Postal code
Phone
+98 38 3334 9509
Fax
+98 33349509
Email
nikmas140@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)