Evaluation the effect of Crocus sativus extract on prevention of nephropathy induced by coronary angiograpy : A triple blind randomized placebo controlled trial
The aim of this study will be to evaluate the effect of saffron extract capsule on prevention of contrast-induced nephropathy in patients undergoing coronary angiography.
Design
Randomised controlled clinical trial and triple blind, parallel study.Each group consists of sixty patients.
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom and is blinded by placebo
Patients undergoing coronary angioplasty are divided into treatment groups with saffron extract capsules and placebo capsules that resemble medication.
Main outcome variables
Serum cratinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031893N6
Registration date:2020-01-06, 1398/10/16
Registration timing:registered_while_recruiting
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Crocus sativus extract on prevention of nephropathy induced by coronary angiograpy : A triple blind randomized placebo controlled trial
Public title
Evaluation the effect of Crocus sativus extract on prevention of nephropathy induced by coronary angiograpy
Patients will be randomly allocated into two groups using random numbers table developed by Random Allocation Software
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment.The placebo is a combination of starch with edible color that is similar to the saffron capsule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.MUQ.REC.1398.100
Health conditions studied
1
Description of health condition studied
Contract induced nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
serum creatinin
Timepoint
3 Day before angiograohy and 3 day after angiography
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment group with saffron extract capsule (containing 1 gram) for 5 days before angiography
Category
Treatment - Drugs
2
Description
Control group: Placebo group with starch capsule (containing 1 gram) for five days before angiography
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahıd Beheshtı Hospital
Full name of responsible person
Seyyed Fakhreddin Hejazi
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719976739
Phone
+98 25 3886 0146
Email
Huqom1394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 4011
Email
huqom1394@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
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
Ghoum University of Medical Sciences
Full name of responsible person
Seyyed Fakhreddin Hejazi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719976739
Phone
009832854011
Email
Huqom1394@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hosseın Yusefi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Yusefi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Kamkar-Arabnia hospital, 19 Day street, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.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