The aim of this study is evaluation of Curcumin effect on cardiac arrhythmia in unstable angina patients. 40 unstable angina patients who fulfilled inclusion and exclusion criteria were randomized in two groups who received Curcumin or placebo in addition conventional drug therapy for treatment of unstable angina. Evaluations are carried out by a physician who are not aware about patients' medication. Blood sampling are taken on days 1, 5, 10 , 15 after intervention. Echocardiography are performed on days 1, 30 and Cardiac monitoring are taken during hospitalization. The effect of Curcumin on atrial and ventricular cardiac arrhythmia and the serum biomarker of atherosclerotic plaque rupturing are compared in these two groups of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102315122N1
Registration date:2014-01-17, 1392/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Masoumeh Salari
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2742
Email address
salarim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashad University of Medical Sciences, Farmacutical research center
Expected recruitment start date
2013-11-05, 1392/08/14
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of curcumin effect on plaque rupturing serum biomarkers and atrial and ventricular arrhythmia in unstabl angina patients.
Public title
Preventive effect of curcumin in cardiac arrhythmia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age>18; diagnosis of unstable angina with clinic and para clinic finding.
Exclusion criteria:
Renal and hepatic failure; infectious diseases; NSIADS and immunosuppresion drugs consumption; curcumin sensitivity; pregnancy and feeding; malignancy; chronic inflammatory disease; cardiac arrhythmia; malabsorption syndromes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashad University Of Medical Sciences
Street address
Goreyshi building, Daneshgah street, Mashad University Of Medical Sciences
City
Mashad
Postal code
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
کد910999
Health conditions studied
1
Description of health condition studied
I20
ICD-10 code
I20.0
ICD-10 code description
Preinfarction syndrome
Primary outcomes
1
Description
frequency of atrial and ventricular arrhythmia
Timepoint
Between first day to 30th day post unstable angina
Method of measurement
ECG-heart exam
Secondary outcomes
1
Description
changes in myeloperoxidase serum concentration
Timepoint
in day 0,5,10,15 post unstable angina
Method of measurement
laboratory
2
Description
changes in matrix metaloproteinase serum concentration
Timepoint
in day 0,5,10,15 post unstable angina
Method of measurement
laboratory
3
Description
Changes in IL-18 serum concentration
Timepoint
in day 0,5,10,15 post unstable angina
Method of measurement
laboratory
Intervention groups
1
Description
Control: Tab Placebo four times per day for two weeks from admission day
Category
Treatment - Drugs
2
Description
Intervention: Tab Curcumin 500 mg four times per day for two weeks from addmission date
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Masoumeh Salari
Street address
Cardiac department, Ghaem hospital, Ahmadabad street
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashad University of Medical Sciences, Pharmaceutical Research Center
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Biulding, Danseshgah Street, Research Vice Chanecellary, Mashhad University of Medical Sciences
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashad University of Medical Sciences, Pharmaceutical Research Center