Determining the effect of garlic pills on quality of life and improving overall heart function and treatment of patients with heart failure
Design
The present study is a randomized clinical trial with a control group receiving placebo and three-blind. The researcher or the person making the measurements, the patients and the data analyzer will be unaware of the drug code and placebo. The study population includes men and women with class III and II heart failure who referred to Isfahan reference offices and met the inclusion criteria.
Settings and conduct
From patients with heart failure referred to Isfahan reference offices, men and women who were in class III and II of the New York Heart Association and are over the age of 18 and have inclusion criteria will be easily selected.
Participants/Inclusion and exclusion criteria
Having heart failure
Unwillingness to continue the cooperation of each unit of research during the study.
Therapeutic use of any natural substances and plants during treatment.
Discontinuation of the drug for any cause or complication or change in the main drugs.
Intervention groups
Patients given garlic medicine
Main outcome variables
Provide herbal therapy based on findings to evaluate and manage the patient's activity and shortness of breath and changes in heart function as measured by echo and blood tests in patients with heart failure
Tests include CBC, PT, ptt, cholesterol, TG, LDL, HDL, FBS, TSH, BUN, Cr
General information
Reason for update
Acronym
garlic
IRCT registration information
IRCT registration number:IRCT20181121041715N1
Registration date:2020-08-18, 1399/05/28
Registration timing:prospective
Last update:2020-08-18, 1399/05/28
Update count:0
Registration date
2020-08-18, 1399/05/28
Registrant information
Name
sima Azish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3611 5209
Email address
sima.azish@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic on quality of life and improvement of cardiac function in patients with heart failure
Public title
The effect of garlic on quality of life and improvement of cardiac function in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart failure in the age range of 18 years and above.
For patients diagnosed at least 3 months in advance according to the New York Heart Association classification in Class III and II
Their discharge fraction is reported to be less than 45%.
Receiving common and standard medications for heart failure.
Women should not be pregnant or breastfeeding and should use safe methods of contraception at reproductive age
Do not suffer from mental illnesses, thyroid, anemia, obstructive pulmonary disease, malignancies, hepatitis, kidney and liver failure, uncontrolled diabetes and uncontrolled hypertension, gastrointestinal diseases.
The patient's blood pressure is below 100/180.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
After that, the eligible patients are listed and based on block randomization, they are divided into two groups of intervention and control.
In the randomized block method, the number of each block is considered to be 4 people. . For example, BABA permutation, so the first person who is eligible and enters the study receives the envelope b or placebo of the second person a or medicine and the third person b and the fourth person a
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is a randomized clinical trial with a control group receiving placebo and three-blind. The researcher or the person making the measurements, the patients and the data analyzer will be unaware of the drug code and placebo. .
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Medical School
Street address
Salman Farsi St. Chamran Heart Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.MUI.MED.REC.1398.273
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
EF
Timepoint
EF-40
Method of measurement
ECKO
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The patient who receives the placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
chamran hospital
Full name of responsible person
davood shafiee
Street address
Salman Farsi St. Chamran Heart Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
d.shafie87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
davood shafiee
Street address
Salman Farsi St. Chamran Heart Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
d.shafie87@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
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
Esfahan University of Medical Sciences
Full name of responsible person
sima azish
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St. Chamran Heart Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
sima.azish@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
davood shafiee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St. Chamran Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
d.shafie87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
sima azish
Position
rezident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi St. Chamran Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1406
Email
sima.azish@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
The results are published and communicated to everyone
When the data will become available and for how long
2020
To whom data/document is available
The results are published and communicated to everyone
Under which criteria data/document could be used
heart Failure
From where data/document is obtainable
dr shafiee
What processes are involved for a request to access data/document