Comparison the effect of garlic with lemon juice on the level of blood pressure and comfort of patients with hypertension Referring to Farshchian Medical Center in Hamedan, 1397
The purpose of this study was to compare the effect of garlic consumption with lemon juice on the blood pressure and comfort of patients with hypertension.
Design
Randomized clinical trial with three groups and control group
Settings and conduct
This study is a clinical trial of three groups before and after the Farshchian heart center of Hamadan. Pateints will be randomly divided into three groups: the Lemon juice group, the recipient of the garlic and the control group. The first group will eat 10 grams of garlic after breakfast and 10 grams of garlic after dinner for 20 days and then relax for a week, during this one week of relaxation measure the blood pressure and comfort of the patient. We take 10 grams of garlic after breakfast and 10 grams of garlic after dinner for another 20 days. We measure blood pressure and comfort again. The second group feeds 10 cc lemon juice a day after breakfast and 10 cc after dinner for 20 days and then resting for a week. In this week, we measure the amount of blood pressure and comfort of the patient. And again for another 20 days, he consumes 10 cc lemon juice a day after breakfast and 10 cc after dinner. We measure the blood pressure and patient comfort again. The third group will receive just the usual treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age is between 18 and 60 years, Have complete and informed consent to participate in the study. No other disease
Exclusion criteria: patient death, Unwillingness to continue participating in the stud
Intervention groups
In the first group, 20 grams of garlic per day for 20 days, and in the second group 10 cc of lemon juice for 20 days will be given daily, and the blood pressure of the patients and their degree of comfort will be evaluated and compared. In the control group, no special action will be taken.
Main outcome variables
Blood pressure, comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N14
Registration date:2018-09-28, 1397/07/06
Registration timing:registered_while_recruiting
Last update:2018-09-28, 1397/07/06
Update count:0
Registration date
2018-09-28, 1397/07/06
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of garlic with lemon juice on the level of blood pressure and comfort of patients with hypertension Referring to Farshchian Medical Center in Hamedan, 1397
Public title
Comparison the effect of garlic with lemon juice on the level of blood pressure and comfort of patients with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age is between 40 and 65 years
Have complete and informed consent to participate in the study
No other disease
Exclusion criteria:
Patient death
Unwillingness to continue participating in the stud
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
105 patients will be selected as available, then using random blocking method, three groups of intervention, placebo and control group will be placed.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.406
Health conditions studied
1
Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Checklist
2
Description
comfort
Timepoint
Before and after intervention
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The first group will eat 10 grams of garlic after breakfast and 10 grams of garlic after dinner for 20 days and then relax for a week, during this one week of relaxation measure the blood pressure and comfort of the patient. We take 10 grams of garlic after breakfast and 10 grams of garlic after dinner for another 20 days. We measure blood pressure and comfort again.
Category
Other
2
Description
Intervention group2: The second group feeds 10 cc lemon juice a day after breakfast and 10 cc after dinner for 20 days and then resting for a week. In this week, we measure the amount of blood pressure and comfort of the patient. And again for another 20 days, he consumes 10 cc lemon juice a day after breakfast and 10 cc after dinner. We measure the blood pressure and patient comfort again.
Category
Other
3
Description
Control group: No special action will be taken.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Khodayar Oshvandi
Street address
Shahid Fahmideh St., Farshchian Hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Khodayar Oshvandi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shahaboddin Bahrani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shahabbahrani72@gmail.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