Determining the Effect of Ginger on Reducing Ischemic-Reducing Injury in Patients with Coronary Angioplasty
Design
Randomized double-blind clinical trial
Settings and conduct
This is a randomized controlled clinical trial that will be carried out in double blind (cardiologist , as well as patients who are not aware of the groups status). . First, the goals of the study will be explained to the patients, and the informed consent will be taken in writing in patients. Then, the 250 mg Zinatuma capsule intervention group of Isfahan Gol daru Company will be given once a day. to the control group the placebo administrated for 10 days. Angioplasty will be performed according to the routine method. . The balloon is then dipped through a catether and placed exactly in the narrowed area with fluoroscopy, and a balloon with a pressure of ten to fourteen atmospheres is kept, and each time lasted for 30 seconds . To measure the determinants of the effects of the preconditioning phenomenon, the two criteria will be determined and recorded in the following ways. The first clinical index for assessing the results is to measure chest pain by scoring a pain .the other parameter of troponin enzyme, which is measured by the Canadian Ramp Company 24 hours after the angioplasty.
Participants/Inclusion and exclusion criteria
1. Having a stenosis of at least 70% in at least one coronary artery
2. Ginger consumption 6 months before study
3. Sensitivity to ginger and its compounds
4. Chest pain 48 hours ago Angioplasty
Intervention groups
In this study, the Zinotoa capsule and the placebo control group received intervention
Main outcome variables
troponin enzyme
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180118038426N1
Registration date:2018-03-04, 1396/12/13
Registration timing:registered_while_recruiting
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Afshin Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 8901
Email address
nazary257@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-25, 1396/12/06
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zingiber officinale Roscoe on reducing ischemia-reperfusion injury in patients undergoing coronary angioplasty
Public title
Zingiber officinale Roscoe on reducing ischemia-reperfusion injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a stenosis of at least 70% in at least one coronary artery
Exclusion criteria:
Ginger consumption 6 months before Study-Ginger sensitivity and its compounds-Chest pain 48 hours before Angioplasty
Age
From 20 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
participants in 8 blocks containing 4 participants in the intervention group and 4 participants in the control group are randomly divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients and researcher are unaware of the grouping patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of lorestan University of Medical Sciences
Street address
moalem ave.khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6963157444
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
ir.lums.rec.1396.261
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
120-125
ICD-10 code description
120-125
Primary outcomes
1
Description
troponin enzyme
Timepoint
24 hours after angioplasty
Method of measurement
labratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, Zinatuma capsule 250 mg is prescribed once a day for 10 days.
Category
Treatment - Drugs
2
Description
Control group: This group is prescribed a placebo capsule for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
madani hospital
Full name of responsible person
afshin nazary
Street address
khirabad ave.khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Fax
+98 66 3312 0133
Email
nazary257@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morvat Kalani
Street address
Khirabad ave. khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Email
nazary257@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
afshin nazari
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
khirabad ave.khorramabad
City
khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Email
nazary257@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
asghar mohamadi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
khirabadave.khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3222 8901
Email
asgharheart@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
asghar mohamadi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
khirabad ave.khorramabad town
City
khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3222 8901
Email
asgharheart@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All original study data is shared
When the data will become available and for how long
All original study data is shared
To whom data/document is available
academic institution
Under which criteria data/document could be used
For use in books and scientific articles
From where data/document is obtainable
Lorestan University of Medical Sciences
What processes are involved for a request to access data/document
with sending Email the study data will be sent within one week