Protocol summary

Study aim
Evaluation of effectiveness of curcumin in preventing nephropathy caused by contrast in coronary angiography
Design
Double-blind, randomized, placebo-controlled clinical
Settings and conduct
This study is conducted in the cardiac angiography department of Afshar Hospital in Yazd. 60 non-emergency patients who undergo coronary angioplasty, were randomly selected in two groups of 30 people, treated and They are controlled. Both groups will receive the original treatment needed. The pills of both groups (curcumin and placebo) are similar in appearance, and the research student and the patient are not aware of the drug content. Patients are receive placebo or curcuma tablets twelve hours before surgery.
Participants/Inclusion and exclusion criteria
Age 18 and above .admitted to Afshar Hospital in Yazd who is undergoing coronary angioplasty as a non-emergency. Not receiving nephrotoxic drugs Not taking medicine containing curcumin in the last month There is no history of allergic reaction following the consumption of oral curcumin. Tolerating the use of oral medications Hospitalization in the cardiac intensive care unit for 2 days Informed consent of the patient himself or his legal guardian, Non-entry criteria Pregnant or lactating mothers Allergy to curcumin
Intervention groups
Patients are selected in a random permutation case to receive placebo or curcuma tablets twelve hours before surgery. The curcumin tablet used is from Dineh company with the brand name Curcuma, each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract. Daru Nama is made by the pharmaceutical laboratory of Shahid Sadoughi Faculty of Pharmacy and it is similar to curcuma drug in terms of shape, size and color.
Main outcome variables
Prevention of contrast- induced nephropathy in coronary angiography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190911044744N4
Registration date: 2023-12-11, 1402/09/20
Registration timing: registered_while_recruiting

Last update: 2023-12-11, 1402/09/20
Update count: 0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Ehsan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 5885
Email address
ehsan.mirzaei.1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of curcumin in the prevention of contrast induced nephropathy in following coronary Angiography: A randomized controlled Trial
Public title
Evaluation of the effectiveness of curcumin in the prevention of contrast induced nephropathy in following coronary Angiography
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older Hospitalized in Afshar Yazd Hospital, who is undergoing coronary angioplasty as a non-emergency. not receiving nephrotoxic drugs. not taking curcumin containing drugs in the past one month and no history of allergic reaction after taking oral curcumin Hospitalization in the cardiac intensive care unit for 2 days Informed consent of the patient himself or his legal guar Informed consent of the patient himself or his legal guardian.
Exclusion criteria:
Pregnant or lactating women Allergy to curcumin Receiving nephrotoxic drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into groups of 30 people and using statistical software;30 people out of 60 patients are completely randomly placed in the treatment group and 30 people in the placebo group. Randomization unit: individual Randomization tool: statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the main researcher, the doctors and the person in charge of data collection are kept blind. In this way, the list of people who are going to take medicine or placebo will be provided to the head of the surgery department with a number.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Faculty of Pharmacy,Yazd, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.178

Health conditions studied

1

Description of health condition studied
Contrast induced nephropathy in following coronary angiography
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome

Primary outcomes

1

Description
Contrast -induced nephropathy in coronary angiography
Timepoint
0-48 hours after surgery
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: recipients of curcuma tablets from Dineh company receive tablet orally 12 hours before coronary angiography to reduce nephrotoxicity of the contrast material and control renal parameters.
Category
Treatment - Drugs

2

Description
Control group: recipients of a placebo prepared in the pharmacy laboratory of Yazd Faculty of Pharmacy in the same size and color as curcuma tablets 12 hours before coronary angiography, receive the tablet orally to reduce the nephrotoxicity of contrast material and control renal parameters.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Ehsan Mirzaei
Street address
Yazd-Jomhouri blvd
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۹۴۵۵۵۶
Phone
+98 35 3525 5011
Email
Ehsan.Mirzaei.1369@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farimah MoshkaniFarahani
Street address
Yazd Faculty of Pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3626 0001
Email
Farimah.Moshkani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of Pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Ehsan.Mirzaei.1369@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of Pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Ehsano.Mirzaei.1369@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farimah Moshkani Farahani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of Pharmacy, Shohada Gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Farimah.Moshkani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...