This is a double blind randomized clinical trial with sample size of 130 patients who undergo on-pump coronary artery bypass surgery at Tehran Heart Center. Patients must have more than 70 score in Wechsler memory scale exam. After obtaining informed consent, patients will be randomized to two different groups. Patients in case group will receive 30 mg saffron per day, three days before surgery till next three months. Patients in control group will be give placebo with the same pattern as case group. Wechsler memory scale test will be done for all patients at three days before surgery, one week after surgery and three months later. Then the scores will be compared between these groups. Furthermore, during the hospitalization, patients will be assessed by a psychologist for detecting delirium.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408071556N63
Registration date:2014-10-29, 1393/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-29, 1393/08/07
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences -Govermental
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing thee effect of Saffron in post operative cognition disorder (POCD) and delirium, in post CABG patients
Public title
Effect of Saffron on reducing recognition problems after cardiac surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 to 70 year-old.
Patients who undergo on-pump cardiac surgery.
Patients who have more than 70 in Wechsler memory scale.
Exclusion criteria:
Patients who do not give informed consent.
Patients who undergo off-pump cardiac surgery.
Patients who undergo valvular surgery.
Patients who are on Warfarin.
Patients with severe arrhythmia.
Patients who have hypersensitivity to Saffron.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-11-05, 1392/08/14
Ethics committee reference number
92-02-30-23285
Health conditions studied
1
Description of health condition studied
Cognitive disorders
ICD-10 code
R48.1
ICD-10 code description
Other and unspecified symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Wechsler memory scale score
Timepoint
Before intervention, one week after surgery, and three months after surgery
Method of measurement
Scores of Wechsler memory scale will be compared
Secondary outcomes
1
Description
Delirium
Timepoint
After intervention and during hospitalization
Method of measurement
Standard Delirium Rating Scale
Intervention groups
1
Description
Participants in case group will receive 30 mg Saffron/day orally (as two 15 mg capsules of Saffron). Saffron will be given to them from 3 days before surgery to 3 months after that.
Category
Treatment - Drugs
2
Description
Participants in control group will receive 30 mg placebo/day (as two capsules of 15 mg placebo). Placebo will be given to them from 3 days before surgery to 3 months after that. The shape, size and color of Saffron and placebo capsules will be same.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Ghods Street, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran Heart Center
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Position
PhD candidate
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 8720
Fax
Email
abbasi.hesam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine, Tehran university of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Faculty of Medicine of Tehran university of Medical Sciences, Poursina Street
City
Tehran
Postal code
1411713138
Phone
+98 21 6641 8466
Fax
Email
s.akond@neda.net
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
ِDr. Seyed Hesameddin Abbasi
Position
PhD Student
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9720
Fax
+98 21 8802 9702
Email
abbasi.hesam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)