<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220815055699N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of medical  salt shaker on blood pressure and urinary sodium</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adjustment Additive Salt with a medical salt shaker on Blood Pressure and 24-Hour Urine Sodium in pre-hypertensive persons</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: By the researcher's colleague, the words intervention and control were written on cards with the same number of samples and put in a bag, and each of the research units randomly took out one of the cards from the bag and thus was placed in the intervention or test group. they got. After the samples with the characteristics of the research units were selected, both groups participated in the training session related to proper diet and the proper diet training pamphlets were given to both groups. And the intervention group participated in the adjustment program of added salt using the daily salt measurement tool. It should be noted that the training session was held by the researcher, Blinding description: The researcher's colleague put the samples into two intervention and control groups, and the samples and the researcher did not know about this issue.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prehypertension.</hc_freetext>
      <i_freetext>Intervention 1: For the intervention group, an educational session was held with the content of explaining the nature of hypertension disease, symptoms of the disease, classification, cause of occurrence and modifiable and non-modifiable risk factors, etc., the importance of how to use a proper diet and the components of the food pyramid, the DASH food pattern, the amount salt, fruits and vegetables, and at the end of the meeting, their questions were answered, and pamphlets containing the training materials, 24-hour urine collection containers, and a medical salt box were provided to each person in the intervention group by the researcher's colleague. The people of the intervention group were emphasized to use only medical salt shakers to add salt to their food.Before the intervention and two weeks and one month after the intervention, their blood pressure was measured, and before and after the intervention, the 24-hour urine sodium of the subjects was measured. Intervention 2: Control group: For the control group, like the intervention group, an educational session was held, with the content of explaining the nature of hypertension, symptoms, classification, cause of occurrence, modifiable and non-modifiable risk factors, etc., the importance of how to use a proper diet and the components of the pyramid. food, the DASH food pattern, the amount of salt consumed and fruit and vegetables, and at the end of the meeting, their questions were answered, and pamphlets containing the taught materials and 24-hour urine collection containers were delivered. And before the start of the intervention, two weeks and one month After the intervention, their blood pressure was measured, and before and after the intervention, the 24-hour urine sodium of the subjects was measured.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic information, blood pressure and urinalysis results can be shared

When:
Access starts one month after results are published

To whom:
Researchers working in academic and scientific institutions and students

Conditions:
There are no special conditions

Where to obtain:
Shokrani@gmail.com

How to obtain:
Within one month from the time of application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra shokrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Allay120/Amirkabir street</address>
        <city>Khomeinishar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8417648462</zip>
        <telephone>+98 31 3363 9810</telephone>
        <email>Shokranizahra@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leila Mardanian Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>mardanian@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Reading and writing literacy  .                                                             2- Not having a speech disorder or hearing disorder .                                                                    3- Living in Isfahan (being available).                                                4- People who are 20-65 years old. and have the ability to perform their daily activities alone.                                                                      5- People who have not used other educational methods and complementary medicine such as massage therapy in the previous three months to control their blood pressure.                                    6- The participants should be of both sexes (non-pregnant women).                                                                                                7- The patients should be interested in participating in the study.                                         8- According to the patient, a history of severe mental stress in six months do not have a past (such as death of relatives and separation from spouse) and are not under severe stress at the time of conducting the research.                                                       9- Having a systolic blood pressure of 120-139 and a diastolic blood pressure of 80-89.                                                                  10- Do not participate in another blood pressure control program.                                                      11- People who, according to their health record, have mental retardation, blindness, deafness, or an active mental illness (schizophrenia) , bipolar disorder and depression) are not severe.                   12- People who are not addicted to narcotics, painkillers and psychotropic drugs.                                                                          13- People who do not have chronic pain syndromes.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having enough motivation to cooperate in the plan and comply with the things taught.
People who had a systolic blood pressure of 14 or higher even once in previous visits to the doctor.
Cases of excessive fluid accumulation in the body such as cirrhosis, etc., use of diuretic drugs, active bleeding or severe sweating.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-I15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the intervention group, an educational session was held with the content of explaining the nature of hypertension disease, symptoms of the disease, classification, cause of occurrence and modifiable and non-modifiable risk factors, etc., the importance of how to use a proper diet and the components of the food pyramid, the DASH food pattern, the amount salt, fruits and vegetables, and at the end of the meeting, their questions were answered, and pamphlets containing the training materials, 24-hour urine collection containers, and a medical salt box were provided to each person in the intervention group by the researcher's colleague. The people of the intervention group were emphasized to use only medical salt shakers to add salt to their food.Before the intervention and two weeks and one month after the intervention, their blood pressure was measured, and before and after the intervention, the 24-hour urine sodium of the subjects was measured</i_keyword>
      <i_keyword>Control group: For the control group, like the intervention group, an educational session was held, with the content of explaining the nature of hypertension, symptoms, classification, cause of occurrence, modifiable and non-modifiable risk factors, etc., the importance of how to use a proper diet and the components of the pyramid. food, the DASH food pattern, the amount of salt consumed and fruit and vegetables, and at the end of the meeting, their questions were answered, and pamphlets containing the taught materials and 24-hour urine collection containers were delivered. And before the start of the intervention, two weeks and one month After the intervention, their blood pressure was measured, and before and after the intervention, the 24-hour urine sodium of the subjects was measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure and 24-hour urine sodium. Timepoint: Before the start of the intervention Two weeks and one month after the start of the intervention. Method of measurement: Mercury sphygmomanometer and 24-hour urine test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-22</approval_date>
        <contact_name>Ethics committee of isfahan University of Medical Sciences</contact_name>
        <contact_address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services اصفهان Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-22</approval_date>
        <contact_name>Ethics committee of isfahan University of Medical Sciences</contact_name>
        <contact_address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services اصفهان Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
