The main objective of this study is to determine the effects of curcumin on left ventricular function in patients undergoing dialysis. The clinical trial will be conducted double-blind, controlled, single centered. Included patients who have chronic kidney failure undergoing dialysis, and the age range of 30-60 years. Patients who are considered outside the age range or known cardiac disease such as CAD or moderate to severe valvular insufficiency (diagnosed by history and noninvasive tests) and informed refusal of consent have excluded. patients will be divided into two groups:case and control. the case group will receive capsule of curcumin 500 mg per 8 hours for six weeks. the control group will receive placebo with the same dose. Before and after six weeks of intervention echocardiography will do and left ventricular ejection fraction that represents left ventricular function and size of the left ventricle will be measured in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011617413N10
Registration date:2015-07-12, 1394/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Atherosclerosis Research Center of Baqiyatallah University
Expected recruitment start date
2013-04-03, 1392/01/14
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin on left ventricle function in patients with end stage renal disease
Public title
The effect of curcumin on heart function
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: all patients with chronic renal failure undergoing dialysis in dialysis center of Baqiyatallah Hospital
exclusion criteria: history of cardiac diseases (due to history taking and non invasive tests); pregnancy and breastfeeding; informed refusal of consent
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
35
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
Baqiyatallah Medical Sciences University Ethic Committee, Atherosclerosis Research Center
Street address
Baqiyatallah Hospital, Molla Sadra Avenue, Tehran
City
Tehran
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
6829
Health conditions studied
1
Description of health condition studied
dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Left Ventricle Ejection Fraction
Timepoint
Baseline, six weeks after the beginning of the study
Method of measurement
Echocardiography
2
Description
Left Ventricle Size
Timepoint
Baseline, six weeks after the beginning of the study
Method of measurement
Echocardiography by measuring volume and diametre of left ventricle
Secondary outcomes
1
Description
Hb
Timepoint
before intervention
Method of measurement
blood sampling
2
Description
PTH
Timepoint
before intervention
Method of measurement
blood sampling
Intervention groups
1
Description
The case group will receive capsule of curcumin 500 mg per 8 hours for six weeks.
Category
Treatment - Drugs
2
Description
The control group will receive placebo 500 mg per 8 hours for six weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Hesam Sadat Hashemi
Street address
Baqiyatallah Hospital, Molla Sadra Avenue, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Atherosclerosis Research Center of Baqiyatallah University
Full name of responsible person
Bahram Pishgoo
Street address
Baqiyatallah Hospital, Molla Sadra Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Atherosclerosis Research Center of Baqiyatallah University
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Hesam Sadat Hashemi
Position
Medical student
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 7710 4021
Fax
Email
seyyedhesam.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Arezoo Khosravi
Position
Assistant professor
Other areas of specialty/work
Street address
Baqiyatallah Hospital, Molla Sadra Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 8248 3419
Fax
Email
arekhosravi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Hamidreza Karimi Sari
Position
Medical student
Other areas of specialty/work
Street address
Baqiyatallah Hospital, Molla Sadra Avenue, Tehran
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)