The purpose of our study was to investigate the effect of silymarin on oxidative agents such as isoprostane, antioxidant factors like catalase and total capacity antioxidant.
this study is randomized , double-blind , controlled placebo trial. The inclusion criteria is age between 18 to 60 years and exclusion criteria are peritonitis in 2 months , hepatitis , using antioxidants drugs such as vitamin C , taking hormones , levothyroxine , and smoking. Number of samples is 60 ( 35 in treatment group, 25 in placebo group) and after 2 months of treatment with a dose of 140 mg every 8 hours, the tests before and after medication was measured then was compared. we expected to see a reduction antioxidant agents and increase in antioxidant enzymes with the use of this drug and also by reducing inflammation leads to improvement of anemia, osteoporosis in short term period and prevention of cancer in long term.
General information
Acronym
CAPD
IRCT registration information
IRCT registration number:IRCT2013110315256N1
Registration date:2013-12-09, 1392/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-09, 1392/09/18
Registrant information
Name
Soraya Khajehrezae
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 64 1525 4526
Email address
khajerezae@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical and Natural Products Chemistry Research Center- Shiraz University Of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Antioxidative Effect of Silymarin on CAPD Patients
Public title
Evaluating the Effect of Silymarin on CAPD Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients undergo Peritoneal Dialysis and are on the follow up of nephrologist at Emam reza Clinic between 18-60 years old.
Exclusion criteria:patients undergo Peritoneal Dialysis who had peritonitis in recent 2 month; hepatitis; or using other antioxidant, anti pregnancy, levothyroxin drugs and smoking.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics commitee of shiraz university of medical sciences
Street address
medicine department, bulding No2, 9th floor, medical ethics group
City
shiraz
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
ct-p-91-3818
Health conditions studied
1
Description of health condition studied
Renal failure, peritoneal dyalisis
ICD-10 code
N17-N19
ICD-10 code description
Renal failure
Primary outcomes
1
Description
glutathione peroxidase antioxidant enzyme in RBC
Timepoint
2 month (before and after drug)
Method of measurement
serlogic blood test
2
Description
antioxidant catalase enzyme
Timepoint
2 month (before and after drug)
Method of measurement
serlogic blood test
3
Description
antioxidant isoprostane enzye F2a
Timepoint
2 month (before and after drug)
Method of measurement
serlogic blood test
4
Description
antioxidant capacity FRAP
Timepoint
2 month (before and after drug)
Method of measurement
serlogic blood test
Secondary outcomes
empty
Intervention groups
1
Description
Receiving silymarin drug 140mg every 8 hours for 2 month
Category
Treatment - Drugs
2
Description
in control group we used similar tablet in shape , color to Silymarin drug, which is consisted of starch as placebo and they should take each hours for 2 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
medical and natural products chemistry research center
Full name of responsible person
Soraya Khajeh Rezae
Street address
Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Roozbeh
Street address
Zand ave.
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 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
Shiraz Universitty of Medical Sciences
Full name of responsible person
Soraya Khajeh Rezae
Position
MD
Other areas of specialty/work
Street address
Shiraz Universitty of Medical Sciences, Namazi hospital, Internist department
City
Shiraz
Postal code
Phone
+98 71 1627 6826
Fax
Email
khajerezae@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soraya Khajeh Rezae
Position
MD
Other areas of specialty/work
Street address
Shiraz Universitty of Medical Sciences- Namazi hospital- internist department
City
Shiraz
Postal code
Phone
+98 71 1627 6826
Fax
Email
khajerezae@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soraya Khajeh Rezae
Position
MD
Other areas of specialty/work
Street address
Shiraz Universitty of Medical Sciences- Namazi hospital - internist department
City
Shiraz
Postal code
Phone
+98 71 1627 6825
Fax
Email
khajerezae@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)