Effect of adding Cinnamon essential oil in the treatment regimen of patients with unipolar non-psychotic major depressive disorder treated with sertraline in postmenopausal women.
Effect of adding Cinnamon essential oil in the treatment regimen of patients with unipolar non-psychotic major depressive disorder treated with sertraline in postmenopausal women.
Design
A clinical trial with parallel groups, double-blind, randomized
Settings and conduct
This study will be a double-blind clinical trial. Forty patients with unilateral major depression of psychotic bread were divided into 2 groups of 20 each. Patients in the first group receive 50 mg of sertraline daily with placebo, the second group receive the same amount of sertraline with 10 drops of cinnamon essential oil daily. Complications and questionnaires are statistically analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with unipolar major depressive disorder diagnosed by a neurologist. Exclusion criteria: patients who have other mental disorders besides unilateral major depression; things like the death of relatives, divorce, marriage, etc. that affect one's mood; Use of other psychiatric drugs.
Intervention groups
We have two intervention groups. the first group of patients is treated with sertraline plus placebo.
Group 2: patients treated with sertraline plus 10 drops of cinnamon essential oil daily.
Main outcome variables
Depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N21
Registration date:2019-10-09, 1398/07/17
Registration timing:prospective
Last update:2019-10-09, 1398/07/17
Update count:0
Registration date
2019-10-09, 1398/07/17
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-29, 1398/08/07
Expected recruitment end date
2020-04-26, 1399/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding Cinnamon essential oil in the treatment regimen of patients with unipolar non-psychotic major depressive disorder treated with sertraline in postmenopausal women.
Public title
Effect of adding Cinnamon essential oil in the treatment regimen of patients with unipolar non-psychotic major depressive disorder treated with sertraline in postmenopausal women
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unipolar major depressive disorder diagnosed by a neurologist
Exclusion criteria:
Patients who have other mental disorders besides unilateral major depression.
Things like the death of relatives, divorce, marriage, etc. that affect one's mood.
Use of other psychiatric drugs.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was randomly divided into two groups of 20 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were placed in envelopes in packages A and B without labeling and without the knowledge of the investigator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.SKUMS.REC.1397.218
Health conditions studied
1
Description of health condition studied
Unipolar Major Depression Disorder
ICD-10 code
F32.3
ICD-10 code description
Major depressive disorder, single episode, severe with psychotic features
Primary outcomes
1
Description
Depression score
Timepoint
Before and after treatment
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients are treated with 50 mg sertraline plus placebo. (Placebo is the distilled water given to patients in a glass similar to a cinnamon drop. Due to the fact that the cinnamon drop has no specific taste and taste, the use of distilled water seems appropriate).
Category
Treatment - Drugs
2
Description
Intervention group: patients treated with sertraline 50 mg daily with 10 drops of cinnamon essential oil daily (cinnamon essential oil extract).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Hourivash Ghaderi
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
H.ghaderi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Seyed Kamal Solati (Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hourivash Ghaderi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
HAjar Hospital, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
h.ghaderi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hourivash Ghaderi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
HAjar Hospital, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
h.ghaderi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hourivash Ghaderi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
HAjar Hospital, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
h.ghaderi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Imam Ali Clinic
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.