<?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>IRCT20110416006202N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Psyllium and Flaxseed on glucose, lipids, and constipation</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Psyllium and Flaxseed on glucose, lipids, and constipation in patients with type 2 diabetes and chronic constipation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomized according to a preexisting list produced by a computer program that differed from a random number generator only in that it assigned equal numbers of patients to each treatment group, and the group assignments were concealed in an opaque sealed envelope, Blinding description: The trial is single-blinded in that patients will be blind to the treatment. Masking of the two treatments was preserved by creating cookies that looked, tasted, and textured identically. The differences in taste were minimal because the prominent flavor was that of the orange-flavor in which cookies was mixed. Because each participant received only one kind of cookie, the participant had no way to compare their cookie with the other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Constipation. Condition 2: Cholesterol and lipid metabolism. Condition 3: ٍElevated blood glucose. Condition 4: BMI.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 2: 10 grams of psyllium mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran. Intervention 2: Intervention 1:10 grams of faxseed mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran. Intervention 3: Control group: Participants in the control group will be received psyllium, falxseed and sugar-free orange-flavored maltodextrin cookies for 12 weeks as placebo. Kamvar Co., Isfahan, Iran.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noreddin Soltanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khoram Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184935331</zip>
        <telephone>+98 913 313 2180</telephone>
        <email>noreddinsol121@gmail.com</email>
        <affiliation>Isfahan Endocrin and Metabolism Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Janghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no. 38, Zohreh Lane, Atash Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184935331</zip>
        <telephone>+98 31 3233 4893</telephone>
        <email>janghorbani@yahoo.com</email>
        <affiliation>Isfahan Endocrine and Metabolism Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients were included if they had type 2 diabetes.
A bowel movement frequency of &lt; 3/week during the past three months.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients were excluded from the study if they had weight loss,
rectal bleeding
abdominal pain
history of opioid use in the last 48 h
pre-existing severe cardiac
endocrinological
hematological
hepatic
renal
metabolic
neurological or psychiatric disorders
Pregnant or nursing women will be excluded
Non-compliant patients during baseline or treatment phases as evaluated by taking &lt;75% of either of the test articles during a one-week period throughout the course of the study will be excluded from the evaluable patient data analysis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59.0</hc_code>
      <hc_code>E78.7</hc_code>
      <hc_code>R73</hc_code>
      <hc_code>Z68</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Constipation</hc_keyword>
      <hc_keyword>Disorders of bile acid and cholesterol metabolism</hc_keyword>
      <hc_keyword>Elevated blood glucose level</hc_keyword>
      <hc_keyword>Body mass index [BMI]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 2: 10 grams of psyllium mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran</i_keyword>
      <i_keyword>Intervention 1:10 grams of faxseed mixed in cookies twice per day for 12 weeks. Kamvar Co., Isfahan, Iran</i_keyword>
      <i_keyword>Control group: Participants in the control group will be received psyllium, falxseed and sugar-free orange-flavored maltodextrin cookies for 12 weeks as placebo. Kamvar Co., Isfahan, Iran</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Constipation intensity. Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: ROME III.</prim_outcome>
      <prim_outcome>Body weight. Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Body mass index and body weight.</prim_outcome>
      <prim_outcome>Lipids . Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Routine measurement of total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol,.</prim_outcome>
      <prim_outcome>Fasting plasma glucose . Timepoint: Beginning, 4, 8, 12 week after intervention. Method of measurement: Oxidase method.</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>2015-04-21</approval_date>
        <contact_name>Isfahan University of Medical Sciences ethic committee</contact_name>
        <contact_address>Hezarjerib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
