To determine the effect of diet and consuming a traditional Iranian medicine syrup or honey and vinegar (Sekanjebin) in preventing anxiety and depression in post CABG patients: a randomized clinical trial
The objective of this study is to evaluate the effectiveness of observing diet and consuming two traditional herbal drugs in decreasing depression symptoms in people who has gone under CABG (Coronary Artery Bypass Graft) operation. In this study patients who refer to Motahari clinic, which is under observe of Shiraz University of Medical Sciences, with coronary artery disease who has undergone CABG operation, after filling informed consent form, are divided by simple randomization into 3 groups of 30 patients (first group: observing diet and consuming a traditional Iranian medicine syrup, second group observing diet and consuming Sekanjebin syrup, third group: control). These drugs are the same in shape and packing, and patients and researchers are blinded to the study (double blind study). Inclusion criteria of this study is CABG operation; and exclusion criteria is positive past history of anxiety and depression disorder under treatment and current usage of antidepressant and anti-anxiety drugs. The traditional Iranian medicine syrup which contains rosewater, saffron and eglantine; and sekanjebin syrup consumes as 3 glasses per day for 4 weeks. All 3 groups will be evaluated by Beck anxiety and depression questionnaire before the study and at the end of 4 weeks. Primary outcome is the degree of decrease in depression and anxiety symptoms, and the secondary outcome is the amount of decrease in antianxiety chemical drug usage at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030921386N1
Registration date:2015-11-25, 1394/09/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Mohaddese Ostovar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 6781
Email address
ostovarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology at Shiraz University of Medical Science
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the effect of diet and consuming a traditional Iranian medicine syrup or honey and vinegar (Sekanjebin) in preventing anxiety and depression in post CABG patients: a randomized clinical trial
Public title
To determine the effect of diet and consuming a traditional Iranian medicine syrup or honey and vinegar (Sekanjebin) in preventing anxiety and depression in post CABG patients: a randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion: CABG operation
exclusion:positive past history of anxiety disorder under treatment; positive past history of depression under treatment; current usage of antidepressant and antianxiety drugs
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Medical Ethics Committee of Shiraz University of Medical Science
Street address
department of medical ethics and philosophy of health, 9th floor, school of medicine
City
Shiraz
Postal code
Approval date
2012-08-30, 1391/06/09
Ethics committee reference number
CT-P-91-3601
Health conditions studied
1
Description of health condition studied
anxiety and depression in post CABG patients
ICD-10 code
197.9
ICD-10 code description
Postprocedural disorder of circulatory system, unspecified
Primary outcomes
1
Description
anxiety and depression
Timepoint
before intervention and 4 weeks following end of intervention
Method of measurement
Beck Depression Score
Secondary outcomes
1
Description
amount of anti-anxiety and antidepressant drugs
Timepoint
4 weeks
Method of measurement
questionnaire
Intervention groups
1
Description
first group: observing diet and consuming 3 glassese per day of a traditional Iranian medicine syrup after CABG for 4 weeks that will be evaluated by Beck questionnaire before the study and at the end of 4 weeks
Category
Treatment - Drugs
2
Description
second group of intervention: consuming 3 glassese per day of honey and vinegar (Sekanjebin) syrup after CABG for 4 weeks that will be evaluated by Beck questionnaire before the study and at the end of 4 weeks
Category
Other
3
Description
third group (control group): will be evaluated by Beck questionnaire before the study and at the end of 4 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Mohadeseh Ostovar
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical science, Vice-Chancellor of Research
Full name of responsible person
Dr.Hashemi S. Basir
Street address
Shiraz University of Medical Sciences, 7th floor, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical science, Vice-Chancellor of Research
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
Ostovar
Full name of responsible person
Mohadeseh
Position
PhD student of Traditional Persian Medicine at Shiraz University of Medical Science
Other areas of specialty/work
Street address
A 13,110 Complex, Golsar 7, 11 alley, Mirzaye Shirazi Blvd.
City
Shiraz
Postal code
Phone
+98 71 3635 6781
Fax
Email
ostovarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical science-Traditional medicine department
Full name of responsible person
Mehdi Pasalar
Position
MD, PhD
Other areas of specialty/work
Street address
Traditional Medicine Department,7th floor, School of Medicine, Zand Blvd.
City
shiraz
Postal code
Phone
+98 71 3230 5886
Fax
Email
pasalar@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of medical Science-Traditional medicine department
Full name of responsible person
Mohadeseh Ostovar
Position
PhD student of traditional Persian medicine
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
+98 71 3635 6781
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)