<?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>IRCT20100408003664N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-26</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of pine bark extract on the treatment of patients with type 2 diabetes with microalbuminuria</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pine bark extract supplementation on metabolic status , serum levels of ICAM-1 and VCAM-1 and anthropometric indeces in type 2 diabetic patients with microalbuminuria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age, sex and BMI variables, Blinding description: A placebo and supplement will be packed in the same number in similar envelopes. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes with microalbuminuria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pine bark extract (Oligopin) will be taken as two capsules of 50 mg with a meal (breakfast and lunch) for 8 weeks, the product of Aramis Faramad Company. Intervention 2: Control group: 50 mg capsule containing starch 2 pcs. Per day with meals (breakfast and lunch) for 8 weeks.</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>Justification or reason for indecision in sharing IPD is Because the research project has not started yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham navval esfahlan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 413335758082</telephone>
        <email>elham.naval@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Navval Esfahlan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 413335758082</telephone>
        <email>elham.naval@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Volunteered to participate in the study with type 2 diabetes
People (men and women) who have been diagnosed with diabetes for at least one year.
Age:Women 30-50 years old  Men: 30-65 years old
Microalbuminuria diagnosis based on ACR criteria in randomized urine specimen</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of congestive heart failure,Infectious diseases of the urine, prostate,Acute febrile illnessUncontrolled blood pressureGlomerulonephritisPolycystic kidney disease,Acute hyperglycemia,The field of hereditary nephropathy
Insulin therapy
smoking
Extreme sports activity (24 hours before sample collection)
Pregnancy-lactation
Use of any type of multi-vitamin supplement and so on during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with renal complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pine bark extract (Oligopin) will be taken as two capsules of 50 mg with a meal (breakfast and lunch) for 8 weeks, the product of Aramis Faramad Company</i_keyword>
      <i_keyword>Control group: 50 mg capsule containing starch 2 pcs. Per day with meals (breakfast and lunch) for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>Level of Serum Insulin. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</prim_outcome>
      <prim_outcome>Homeostatic Model Assessment of Insulin Resistance(HOMA-IR). Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Calculated According to The Formula.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With HPLC.</prim_outcome>
      <prim_outcome>Total Cholestrol. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotometer.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Calculated According to The Friedwald Formula.</prim_outcome>
      <prim_outcome>TG. Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With Spectrophotomete.</prim_outcome>
      <prim_outcome>ICAM-1(Intra cellular adhesion molecule1). Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</prim_outcome>
      <prim_outcome>VCAM-1( vascular cell adhesion molecule 1 ). Timepoint: Before of Intervention and 8 Weeks After Intervention. Method of measurement: Blood Sampling and Analysing With ELISA.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-24</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz - GolgaSht - Attar Neyshabour Ave - Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
