<?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>IRCT2017072535305N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-16</date_registration>
      <primary_sponsor>Shahid Modarres Clinical Research Center,Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of oral administration of Allium sativum on lipid profile,inflammatory indexes, function and structure of peritoneal membrane in patients on peritoneal dialysis</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of oral administration of Allium sativum on lipid profile,inflammatory indexes, function and structure of peritoneal membrane in patients on peritoneal dialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26723</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Z49.2.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, patients  received 400 mg of standard garlic powder extract tablets twice aday for 8 weeks. each tablet contains 1000 micrograms of alliin.&#13;
The drug was produced by the Amin pharmaceutical company. Intervention 2: In the control group, The placebo was prescribed.The placebo was completely similar to the original drug and it was made of starch.and it also The drug was produced by the Amin pharmaceutical company.</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>Amirhesam Alirezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2208 3112</telephone>
        <email>Amirhesam124@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhesam Alirezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2208 3095</telephone>
        <email>amirhesam124@gmail.com</email>
        <affiliation>Shahid Modarres Hospital,Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria :&#13;
Recent use of medicines and foods that contain garlic; sensitivity to garlic; history of bleeding; disorders and use of warfarin; history of infection or hospitalization inthe last 3 months; unwillingness to continue to participate in the research project; history of gastric bypass; do not use more than 80% of medicine. &#13;
Inclusion criteria :&#13;
age above 18; six months have passed since the onset of peritoneal dialysis.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, patients  received 400 mg of standard garlic powder extract tablets twice aday for 8 weeks. each tablet contains 1000 micrograms of alliin.&#13;
The drug was produced by the Amin pharmaceutical company.</i_keyword>
      <i_keyword>In the control group, The placebo was prescribed.The placebo was completely similar to the original drug and it was made of starch.and it also The drug was produced by the Amin pharmaceutical company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profil,TG.CHOL.HDL.LDL in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>IL6 in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>ESR in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Albumin in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>CRP in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Ferritin in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Homocysteine in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>CBC.diff in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Serum iron in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Peritoneal equilibration test in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Blood pressure in control group. Timepoint: Before and after intervention. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Weight in control group. Timepoint: Before and after intervention. Method of measurement: Scale.</prim_outcome>
      <prim_outcome>ASt in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>ALT in control group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Lipid profil,TG.CHOL.HDL.LDL. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>IL6 in case group in cases group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>ESR in cas3 group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Albumin in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>CRP in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Ferritin Fein case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Homocysteine in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>CBC.diff in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Serum iron in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Peritoneal equilibration test in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>Blood pressure Blin case group. Timepoint: Before and after intervention. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Weight in case group. Timepoint: Before and after intervention. Method of measurement: Scale.</prim_outcome>
      <prim_outcome>AST in case group. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
      <prim_outcome>ALT in case gruop. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement.</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>Shahid Modarres Clinical Research Center,Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-16</approval_date>
        <contact_name>Shahid modarres hospital</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
