Comparison Of The Effect Of Mint And Cumin Extract On The Severity Of Flatulence In Patients After Coronary Artery Bypass Graft
Design
In this study, 70 patients who are undergoing coronary artery bypass grafting and are eligible for inclusion in the study are selected. Participants are randomly divided into intervention groups A and B, and each participant is assigned a code.
Settings and conduct
Farshchian hospital cardiac intensive care unit Hamedan
Participants/Inclusion and exclusion criteria
1. Patients who are elevated under the coronary artery bypass graft
2. Age between 40-70 years
3. Lack of abdominal bloating before CABG surgery
4. Full vigilance and enough visual sight
5. Having bloating within 48 hours after the CABG operation with a score of at least 1 and more than the visual scale
6. The ability and readiness of the patient to swallow
7. Not susceptible to medicinal herbs, according to the patient
8. Not having a nose-stomach tube
Intervention groups
Intervention group A: The Cumin extract is given to the patient to evaluate the Effect On The Severity Of Flatulence
Intervention group B:The mint extract is given to the patient to evaluate the Effect On The Severity Of Flatulence
Main outcome variables
Use cumin and mint herbal medicines to treat flatulence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171207037779N1
Registration date:2018-01-08, 1396/10/18
Registration timing:prospective
Last update:2018-01-08, 1396/10/18
Update count:0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Arash Maghsood
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 9211
Email address
ar.maghsoud@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effect Of Mint And Cumin Extract On The Severity Of Flatulence In Patients After Coronary Artery Bypass Graft
Public title
Comparison Of The Effect Of Mint And Cumin Extract On The Severity Of Flatulence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
Exclusion criteria:
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method Using Permutable Blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are randomly divided into two groups of interventions and the patient is unaware of the type of medication he takes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of hamedan University of Medical Sciences
Street address
Hamadan University of Medical Sciences,shahid fahmideh street, Hamedan, Iran
City
hamedan
Province
Hamadan
Postal code
8698365178
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.UMSHA.REC.1396.628
Health conditions studied
1
Description of health condition studied
Flatulence
ICD-10 code
R14.3
ICD-10 code description
Flatulence
Primary outcomes
1
Description
Severity Of Flatulence
Timepoint
Determine the severity of flatulence in 4 times: before the intervention, 20 minutes after the first intervention, twenty minutes after the second intervention and 120 minutes after the end of the intervention.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group receiving Mint Extract receive 40 drops of Mint Extract in 30 cc of urban tap water in three consecutive intervals of 20 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: The group receiving cumin Extract receive 40 drops of Mint Extract in 30 cc of urban tap water in three consecutive intervals of 20 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Cardiovascular Subspecialty Hospital
Full name of responsible person
Mohsen Salavati
Street address
Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
000000000000000
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh blvd
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
salavatimohsen42@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh blvd
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
salavatimohsen42@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh blvd
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
salavatimohsen42@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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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