Determining the effect of dietary recommendations related to traditional Iranian medicine on blood pressure
Design
Clinical trials have an intervention group, with a parallel, single blind, randomized group, on 50 patients in each group. For randomization,Limited randomization method (Random allocation rule) was used.
Settings and conduct
Since the main action in controlling blood pressure in people who are in the pre-hypertensive stage is lifestyle modification,in this study, which is done in a single blind , we will try to examine the effect of modifying eating habits based on the principles of traditional Iranian medicine on the blood pressure of these people. At the outset Be checked Blood pressure. People will be monitored for one month to check their compliance with the instructions, as well as record their daily activity and diet in the delivered forms. On the 30th day, they will be invited again and their blood pressure will be measured.Nutritionist and evaluators will not be aware of the type of membership in the intervention and control group .This study is performed at the Cardiac Research Center of Afshar Hospital in Yazd.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients who are in the stage of prehypertension and have no evidence of secondary hypertension, Patients in the age range of 25 to 55 years
Exclusion criteria
Patients who enter the next stages of high blood pressure during the period, and those who suffer from cardiovascular disease and other diseases.
Intervention groups
In the intervention group, the correct method of eating will be taught according to the instructions of traditional Iranian medicine and also the training of blood pressure control diet. In the control group, only blood pressure control diet training will be given.
Main outcome variables
systolic blood pressure, diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200524047558N1
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
hossein abolhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 9824 5367
Email address
h.abolhosseini@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of dietary habit corrected by Iranian traditional medicine on blood pressure in patients with hypertension (HTN)
Public title
Evaluation dietary habit corrected by Iranian traditional medicine on blood pressure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are in the pre-hypertension stage and have no evidence of secondary hypertension.
Patients in the age range of 25 to 55 years
have a minimum diploma education
Exclusion criteria:
Patients with hypertension who enter the next stages of the disease.
Those who have complications following dietary recomendation
People with cardiovascular disease and other chronic diseases
Those who have not complied with the relevant recommendations for more than one consecutive week or two Intermittent weeks
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize, a limited randomization model (Random allocation rule) will be performed, in which a ball of the same color and shape will be poured into a container. Will select and based on that the intervention and control group will be identified
Blinding (investigator's opinion)
Single blinded
Blinding description
Invited patients who have been randomly assigned to two intervention and control groups will be trained on a blood pressure control diet separately after obtaining informed consent. Also, in the intervention group,Dietary recommendations training based on traditional Iranian medicine will be given. The Pamphlets and delivery forms in both groups have the same shape and there is no difference in their appearance. A nutritionist who is responsible for the nutrition counseling of both groups will not be aware of the type of membership in the intervention and control group and will equally follow the diet training. Evaluators of the primary and secondary consequences will also not be aware of the type of membership of the individuals studied.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine , Kerman
City
Kerman
Province
Kerman
Postal code
7618843883
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.KMU.REC.1398.732
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
The amount of blood pressure systolic and diastolic
Timepoint
The first day of study and the 30th day of study
Method of measurement
Breuer digital blood pressure monitor
Secondary outcomes
1
Description
Weight
Timepoint
The first day of study and the 30th day of study
Method of measurement
Breuer digital scales
2
Description
Waist circomference size
Timepoint
The first day of study and the 30th day of study
Method of measurement
Meter
3
Description
neck circomference size
Timepoint
The first day of study and the 30th day of study
Method of measurement
Meter
4
Description
body mass index
Timepoint
The first day of study and the 30th day of study
Method of measurement
calculation
5
Description
body fat mass
Timepoint
The first day of study and the 30th day of study
Method of measurement
calculation
6
Description
blood Triglyceride
Timepoint
The first day of study and the 30th day of study
Method of measurement
Autoanalyzer device
7
Description
blood Cholesterol
Timepoint
The first day of study and the 30th day of study
Method of measurement
Autoanalyzer device
Intervention groups
1
Description
Intervention group:In this group, first, the level of awareness of dietary habit based on Iranian traditional medicine is measured.Then the necessary training is given to follow these instructions and also the diet to control blood pressure is taught.During one month, the compliance with these instructions as well as the diet is controlled.
Category
Lifestyle
2
Description
Control group: In this group, only the necessary training to follow the blood pressure control diet is given, and during one month of study, the observance of these diets is controlled.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Cardiovascular Research Center
Full name of responsible person
Dr. Seyed Mostafa Seyed Hosseini
Street address
Afshar Hospital Jomhouri Boulevard. Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3523 1420
Fax
+98 35 3523 1421
Email
yazdheartcenter@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhi
Street address
at the beginning of Ibn Sina Street ,Somayeh Crossroads,Deputy of Research and Technology,kerman medicalunivercity
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
kmu_research@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mohammad Satayesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine,kerman
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Fax
+98 34 3211 0120
Email
msetayeshmail@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mohammad Satayesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine,kerman
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Fax
+98 34 3211 0120
Email
msetayeshmail@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Abolhosseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine,kerman
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Fax
+98 34 3211 0120
Email
dr.abolhosseini@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
After identifying the participants' details, the information about the main consequences will be shared
When the data will become available and for how long
one year after the end of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers, the use of the questionnaire and the consent form, as well as statistical information of the study, if the proposal is sent and the intellectual rights of the researcher are unrestricted
From where data/document is obtainable
Email msetayeshmail@gmail.com
What processes are involved for a request to access data/document
If you are working in a university or scientific institution, it is necessary to provide the relevant document, and the reason for the need for the requested information and the type of relationship with the other study is requested.