<?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>IRCT2017070434897N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>effect of the traditional medicine on health during fasting</public_title>
      <acronym></acronym>
      <scientific_title>Assessment and compression of the influence of traditional medicine based food regime and behavior on anthropometric indexes, blood tests, and mental health in adult fasting Muslims in Shiraz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26544</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>traditional medicine based food regime and behavior.</hc_freetext>
      <i_freetext>Intervention 1: Type of intervention in Intervention group:&#13;
Traditional medicine tips training will be done through a booklet which published by Office of Traditional Medicine of the Ministry of Health of Iran in person within half an hour in Intervention group. In this booklet there are many tips about Less consuming sweets and industrial foods, consumption of warm liquid in breakfast time, avoiding Eating different foods at the same time, Full food chewing on meals, avoiding consumption of water and food Simultaneously. Intervention 2: Type of intervention in control group:&#13;
For the control group, Traditional medicine tips training and consultation will not be done. (No action).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Hossein Owji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Square- Medical School</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 000</telephone>
        <email>owji_h@sums.ac.irs.h.owji.j.e@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdi Pasalar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Square- Medical School</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3233 8476</telephone>
        <email>pasalar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Ages between 18 to 60 years which can afford fasting; People who tend to fast during Ramadan and this Ramadan is not their first fasting time.&#13;
Exclusion criteria:&#13;
having uncontrolled hypertension or malignant hypertension; having severe neurological disease (depression, schizophrenia, and addiction); having severe medical disease (diabetes, hyperlipidemia, cancer and rheumatologic disorder); Pregnant and lactating mothers; having swallowing problem, under therapeutic regime or having body mass index under 20 or above 40 kilograms per square meters; having history of at least 15 days fasting during 2mouths before Ramadan; having at least 5 days not fasting during Ramadan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lifestyle-related condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Type of intervention in Intervention group:&#13;
Traditional medicine tips training will be done through a booklet which published by Office of Traditional Medicine of the Ministry of Health of Iran in person within half an hour in Intervention group. In this booklet there are many tips about Less consuming sweets and industrial foods, consumption of warm liquid in breakfast time, avoiding Eating different foods at the same time, Full food chewing on meals, avoiding consumption of water and food Simultaneously.</i_keyword>
      <i_keyword>Type of intervention in control group:&#13;
For the control group, Traditional medicine tips training and consultation will not be done. (No action)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood urea nitrogen(BUN). Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>Height. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: By meter, in cm.</prim_outcome>
      <prim_outcome>Weight. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: By balance, in kg.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: by Mercury barometric- in mm Hg.</prim_outcome>
      <prim_outcome>Round the abdomen. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: By meter, in cm.</prim_outcome>
      <prim_outcome>Hip circumference. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: By meter, in cm.</prim_outcome>
      <prim_outcome>Mental Health Indicators. Timepoint: before Intervention, after Intervention, three mouths after Intervention. Method of measurement: By questionnaires: WQ5، HAD5، IPAQ، HQ28.</prim_outcome>
      <prim_outcome>Fasting blood suger. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>LDL cholesterol. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>HDL cholesterol. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</prim_outcome>
      <prim_outcome>AST. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in u/L.</prim_outcome>
      <prim_outcome>ALT. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in u/L.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: before Intervention, after Intervention. Method of measurement: by standard device- in mg/dl.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-20</approval_date>
        <contact_name>Shiraz University of medical sciences</contact_name>
        <contact_address>Shiraz University of medical sciences, Zand street, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
