<?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>IRCT20200524047558N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation  dietary habit corrected by Iranian traditional medicine on blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of dietary habit corrected by Iranian traditional medicine on blood pressure in patients with hypertension (HTN)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48414</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</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:
After identifying the participants' details, the information about the main consequences will be shared

When:
one year after the end of the study

To whom:
Researchers working in academic and scientific institutions

Conditions:
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

Where to obtain:
Email msetayeshmail@gmail.com

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Satayesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine,kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>msetayeshmail@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Satayesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine,kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>msetayeshmail@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: The first day of study and the 30th day of study. Method of measurement: Breuer digital scales.</sec_outcome>
      <sec_outcome>Waist circomference size. Timepoint: The first day of study and the 30th day of study. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Neck circomference size. Timepoint: The first day of study and the 30th day of study. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: The first day of study and the 30th day of study. Method of measurement: calculation.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: The first day of study and the 30th day of study. Method of measurement: calculation.</sec_outcome>
      <sec_outcome>Blood Triglyceride. Timepoint: The first day of study and the 30th day of study. Method of measurement: Autoanalyzer  device.</sec_outcome>
      <sec_outcome>Blood Cholesterol. Timepoint: The first day of study and the 30th day of study. Method of measurement: Autoanalyzer  device.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-24</approval_date>
        <contact_name>Ethics committee of kerman University of Medical Sciences</contact_name>
        <contact_address>Amir Kabir Crossroads, in front of the Faculty of Engineering, next to Shahid Mahdavi High School, Faculty of Traditional Iranian Medicine , Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
