Comparison between an Iranian Traditional Medicine pharmaceutical product and fatty substance on reduction of liver and gallbladder disturbing shadow in myocardial perfusion imaging with Tc-MIBI
The aim of this study is to evaluate the effectiveness of a novel pharmaceutical product of Iranian Traditional Medicine (syrup is made on the basis of sour cherry juice) on reducing the intrusive activity of the liver and gallbladder, in comparison with fatty food (which is the most frequently used material in myocardial imaging). In this randomized clinical trial, patients between 18 to 70 years coming for myocardial imaging enter the study, excluding patients with liver problems. The sample size is 60 patients who are categorized into 2 groups. In the control group, patients use 100 gr of fatty food while in the intervention group, patients use 200cc of traditional syrup, 10 minutes after radiopharmaceutical injection. Then, imaging is performed through radiopharmaceutical radiation 30, 60 and 90 minutes following the injection. After analyzing the images, determination of heart to liver and gallbladder counts ratio, comparison of the average value in each group, and the effectiveness of materials in comparison with each other are determined. The quality of the images can be improved via increasing the average value.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071215860N4
Registration date:2016-10-27, 1395/08/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-27, 1395/08/06
Registrant information
Name
Ghazaleh Heydarirad
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6027
Email address
dr.ghazalrad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Traditional Medicine Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between an Iranian Traditional Medicine pharmaceutical product and fatty substance on reduction of liver and gallbladder disturbing shadow in myocardial perfusion imaging with Tc-MIBI
Public title
Comparison between an Iranian Traditional Medicine pharmaceutical product and fatty substance on reduction of liver and gallbladder disturbing shadow in myocardial perfusion imaging
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients who refer by cardiologists to Nuclear medicine center of Imam Khomeini hospital for performing perfusion scan; patients between 18 to 70 years; Hyperlipidemic patients; Unwillingness to use fat; Feeling of nausea when patients eat fat
Exclusion criteria: Patients who suffer from certain diseases such as heart disease or liver and bile ducts disorders; Pregnancy; Known active infection; An identified blood laboratory abnormalities at baseline; Peptic ulcer or biliary obstruction or gallstones
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
keshavarz boulevard, Tehran University of Medical Science
City
Tehran
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
9002611376558211
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Amount of clearing the intrusive activity of the liver
Timepoint
30 and 60 and 90 minutes after administering radioactive substance
Method of measurement
Measuring Heart/Liver ratio by observation and ratio determination of numeration of the heart to the liver
2
Description
Amount of clearing the intrusive activity of the gallbladder
Timepoint
30 and 60 and 90 minutes after administering radioactive substance
Method of measurement
easuring Heart/gallbladder ratio
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Drinking 200 cc of a pharmaceutical product (syrup) of Iranian traditional medicine, 10 min after radiopharmaceutical administration.
.
Category
Diagnosis
2
Description
Control group: using 100 gr of fatty food , 10 min after radiopharmaceutical administration.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear medicine department, Imam Khomeini hospital
Full name of responsible person
Dr. Saeed Farzanefar
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.Hossein Rezaeizade
Street address
Faculty of Traditional Medicine, west Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine Shahid Beheshti University of Med
Full name of responsible person
Ghazaleh Heydarirad
Position
MD, PhD of traditional medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Vali-e-Asr Street Tehran, Iran
City
Tehran
Postal code
Phone
+98 21887735235
Fax
Email
dr.ghazalrad@sbmu.ac.irghazalrad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nuclear medicine, Tehran university of medical sciences
Full name of responsible person
Saeed Farzanehfar
Position
Assistant professor, Nuclear Medicine Specialist
Other areas of specialty/work
Street address
Nuclear Medicine Department, Imam KhomeiniHospital, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3198 8253
Fax
Email
farzanehfar@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine Shahid Beheshti University of Med
Full name of responsible person
Ghazaleh Heydarirad
Position
MD, PhD of traditional medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Vali-e-Asr Street Tehran, Iran
City
Tehran
Postal code
Phone
+98 21887735235
Fax
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)