<?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>IRCT138706111157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-04-11</date_registration>
      <primary_sponsor>Jahad Daneshgahi</primary_sponsor>
      <public_title>The efficacy of Rheum ribes L stalk extract on lipid profile in hypercholesterolemic type II diabetic patients. A randomized, double-blind, placebo-controlled, clinical trial.</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of Rheum ribes L stalk extract on lipid profile in hypercholesterolemic type II diabetic patients a randomized, double-blind, placebo-controlled, clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2006-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypercholesterolemia.</hc_freetext>
      <i_freetext>Intervention 1: Placebo capsule 400 mg 3 times a day treatment orally for one month. Intervention 2: Rheum Ribes 400 mg capsule 3 times a day treatments orally for one month.</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>Hassan Fallah Huseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahad daneshgahi research society, Tehran-Qazvin Highway</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31375369</zip>
        <telephone>+98 261476401019</telephone>
        <email>fallah@imp.ac.ir      huseini_fallah@yahoo.com</email>
        <affiliation>Institute of Medicinal Plants, ACECR</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Fallah Huseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahad-Daneshgahi research society (ACECR) Tehran-Qazvin Highway,</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31375369</zip>
        <telephone>+98 261476401019</telephone>
        <email>fallah@imp.ac.ir    huseini_fallah@yahoo.com</email>
        <affiliation>Institute of Medicinal Plants</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age between 40 to 60 years, serum cholesterol above 100 mg/dl, confirmed type II diabetes at least for two years with fasting blood glucose above 150-250 mg/dl taking Metformin or Glibenclamid, HbA1c 7.5-10%, not taking any antihypercholesterolmic drug during past month, signing the written informed consent. &#13;
Exclusion criteria: Insulin therapy, infectious diseases, severe kidney, liver, heart and pulmonary diseases, hypersensitivity to any drug, foot ulcer or gangrene, major depressive disorder, previous myocardial infarction, active cancer or previous cancer during past 5 years, history of alcohol consumption or cigarette smoking, pregnancy, breast feeding.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of lipoprotein metabolism and other lipidaemias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code></i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Placebo capsule 400 mg 3 times a day treatment orally for one month</i_keyword>
      <i_keyword>Rheum Ribes 400 mg capsule 3 times a day treatments orally for one month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LDL cholesterol. Timepoint: Baseline and after one month. Method of measurement: The fasting serum LDL cholesterol concentration determined in blood sample by calculating HDL and total cholesterol level.</prim_outcome>
      <prim_outcome>Blood glucose. Timepoint: Baseline and after one month. Method of measurement: The fasting serum glucose  concentration determined in blood sample by glucose oxidase method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total cholesterol. Timepoint: Baseline and after one month. Method of measurement: The fasting serum total cholesterol level in blood sample by enzymatic oxidase method.</sec_outcome>
      <sec_outcome>HDL. Timepoint: Baseline and after one month. Method of measurement: The fasting blood HDL level in blood sample by CDC designated comparison method.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Baseline and after one month. Method of measurement: The fasting blood Triglyceride level in blood sample by enzymatic oxidase method.</sec_outcome>
      <sec_outcome>SGOT. Timepoint: Baseline and after one month. Method of measurement: The fasting blood SGOT level in blood sample by DGKG enzymatic method.</sec_outcome>
      <sec_outcome>SGPT. Timepoint: Baseline and after one month. Method of measurement: The fasting blood SGPT level by DGKG enzymatic method.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: Baseline and after one month. Method of measurement: The fasting blood Creatinine level in blood sample by JAPH enzymatic method.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Endocrinology &amp; Metabolism Research Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Jahad Daneshgahi</source_name>
      <source_name>Endocrinology &amp; Metabolism Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2005-11-10</approval_date>
        <contact_name>Endocrinology &amp; Metabolism Research Center, Tehran University of Medical Sciences</contact_name>
        <contact_address>Endocrinology &amp; Metabolism Research Center, Tehran University of Medical Sciences Tehran IR IRAN Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
