1. Determining the effect of Nervoxin on Liver clearance of 99mTc-MIBI in Human’s Myocardial Perfusion Scan
2. Determination the heart and liver activity in both control and intervention groups and comparing them with each other
3. Determining the heart to liver activity ratio in both control and intervention groups and comparing them with each other
Design
َA clinical trial with control and intervention groups on 60 patients
Settings and conduct
60 patients are selected from the patients referred to nuclear medicine department of Fatemeh Zahra hospital and are classified into two groups of control and intervention. 30 patients are daily received 900mg of Nervoxin for 5 days. 24 hours after the last dose, the Myocardial perfusion (MPI) scan will be performed in accordance with the standard protocols. 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.
Participants/Inclusion and exclusion criteria
Patients without previous history of cholecystectomy; liver- biliary disease; hepatic and renal failure, coagulopathy; history of myocardial infarction and heart valve disease and heart failure and patient who don't take medicine such as digoxin, warfarin and theophyllin are enrolled in the study.
Intervention groups
Intervention group: 30 patients are received nervoxin 5 days before scanning, which is discontinued for 24h before Myocardial perfusion (MPI) scan.
Control group: 30 people with no additional intervention prior to Myocardial perfusion (MPI) scan.
Main outcome variables
1- Increased liver clearance of 99mTc-sestamibi
2- Increased hear to liver radioactivity ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200803048277N1
Registration date:2020-10-14, 1399/07/23
Registration timing:registered_while_recruiting
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Zohreh Noaparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3463 2525
Email address
z_noaparast@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Nervoxin commercial herbal medicine on liver clearance of 99mTc-Sestamibi in human’s myocardial perfusion scan
Public title
effect of Nervoxin on hepatic clearance of 99mTc-Sestamibi
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients except patients taking drugs that interact with nevroxin, such as digoxin, warfarin, theophylline, etc.
All patients except those with known hepatic and renal failure, patients with coagulation problems and heart disease.
Exclusion criteria:
Patients taking drugs that interact with nevroxin, such as digoxin, warfarin, theophylline, etc.
People with known hepatic and renal failure, patients with coagulation problems and heart patients
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4715733971
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.MAZUMS..REC.1399.7985
Health conditions studied
1
Description of health condition studied
Myocardial perfusion
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
99mTc-MIBI accumulation in liver
Timepoint
24 hours after receiving the last dose of Nervoxin
Method of measurement
Imaging with gamma camera
2
Description
Heart to liver activity ratio
Timepoint
24 hours after receiving the last dose of Nervoxin
Method of measurement
Imaging with gamma camera
Secondary outcomes
1
Description
Difference Score in liver clearance of 99mTc-MIBI between control and intervention groups
Timepoint
After myocardial perfusion scan
Method of measurement
Imaging with gamma camera
Intervention groups
1
Description
Intervention group: 30 patients received Nervoxin drug
Category
Diagnosis
2
Description
Control group: 30 patients who don't recieve any intervention
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Department of Fateme Zahra hospital
Full name of responsible person
Zohreh Noaparast
Street address
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
City
Sari
Province
Mazandaran
Postal code
4715733971
Phone
+98 11 3304 4000
Email
z_noaparast@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Moalem Sq., Sari., Mazandaran., Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
publicrel@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology, Mazandaranl University of Medical Scenices
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
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Noaparast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
z_noaparast@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Noaparast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3463 2525
Fax
+98 11 3354 3084
Email
z_noaparast@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Noaparast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam academic complex, 18 km of Khazar Abad Ave, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3463 2525
Fax
+98 11 3354 3084
Email
z_noaparast@yahoo.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
At the end of the study, details of the study method, statistical analysis and results related to cardiac perfusion scans in patients will be published in detail as a research article.
When the data will become available and for how long
Access to the data file and details of the results is possible after the publication of the article
To whom data/document is available
Only reputable academic institutions, especialy medicinal researcher will be allowed to receive data
Under which criteria data/document could be used
Researchers who study on myocardial perfusion scan
From where data/document is obtainable
Applicants can receive the information via the mentioned email address
Dr. Zohreh Noaparast: z_noaparast@yahoo.com, z.noparast@mazums.ac.ir
Dr. Seyed Mohammad Abedi: mabedi167@yahoo.com
What processes are involved for a request to access data/document
Email to the applicant - request from University Research Assistant - If their opinion is positive, information will be provided to the applicant