Effect of kefir drink on hepatic activity discharge
Design
The clinical trial , has a control group. with a parallel and randomized group
Settings and conduct
The design is done in the Nuclear Medicine Department of Imam Ali Hospital in Kermanshah hospital's nuclear medicine , where the population is divided into two groups, fed to one group according to the usual routine of milking and kefir to the other group. We are not aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with a technetium-based heart scan are eligible to participate.
Exclusion criteria: People with a history of fatty liver or gall bladder.
Intervention groups
The study group is divided into two groups: one group consumes 250 ml of kefir 20 minutes after the injection of the radioactive drug and the second group receives 250 ml of milk as usual.
Main outcome variables
Activity under diaphragm
Hepatic activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200104046005N1
Registration date:2020-01-29, 1398/11/09
Registration timing:registered_while_recruiting
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Simin Pirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 8845
Email address
30minpirzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Kefir Drinks with Milk on Decreased Liver Activity in Cardiac Scan
Public title
Effect of kefir on reducing liver activity
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
All patients for whom a heart nuclear scan with Tc Sestamibi scan requested
Exclusion criteria:
Patients with fatty liver
Patients who have had bile surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the specialist physician who reports the results of the scan and the investigator were not included in the intervention to prevent bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Scienes
Street address
Refah Street
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.KUMS.REC.1398.692
Health conditions studied
1
Description of health condition studied
Myocardial perfusion
ICD-10 code
R94.39
ICD-10 code description
Abnormal result of other cardiovascular function study
Primary outcomes
1
Description
Effect of Kefir Drink on Liver Activity Reduction
Timepoint
Thirty minutes after drinking kefir
Method of measurement
Response performed by a specialist physician from the scan result.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, Kefir drinks with Pegah brand are used. To ensure that the compound is used and the elements that influence the scanning process before using the compound, perform cognitive tests, synthetic analysis, and gas testing at the food industry laboratory or carbonate plant laboratories such as Zamzam on the drink. Kefir is very important. The heart scan process will be performed in accordance with standard protocols. Patients were randomly selected from patients referred to Imam Ali Hospital. 100 patients were given 250 ml of kefir drink 30 minutes before scanning. Finally, all data obtained from human heart myocardial perfusion scans will be processed at the center and will be sorted by professors and quantified as statistical data.
Category
N/A
2
Description
Control group: 100 people with no additional intervention and routine scanning routine.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Simin Pirzadeh
Street address
Refah street
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Phone
+98 83 3837 0252
Email
30minpirzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Najafi Farid
Street address
Refah stereet
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Phone
+98 21 8670 5505
Email
30minpirzadeh@gail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Simin Pirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nuclear Medicine
Street address
Refah Street
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Phone
+98 21 8670 5505
Email
30minpirzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Simin Pirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nuclear Medicine
Street address
Refah street
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Phone
+98 84 3522 8845
Fax
Email
30minpirzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Simin Pirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nuclear Medicine
Street address
Refah street
City
Kermanshah
Province
Kermanshah
Postal code
6961814547
Phone
+98 84 3522 8845
Fax
Email
30minpirzadeh@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient data and research results are shared after individuals are unidentified.
When the data will become available and for how long
After pablish the results
To whom data/document is available
Access is allowed for everyone
Under which criteria data/document could be used
Any type of data analysis is allowed
From where data/document is obtainable
Email 30minpirzadeh@gmail.com
What processes are involved for a request to access data/document