<?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>IRCT138706161157N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-04-13</date_registration>
      <primary_sponsor>Jahad Daneshgahi</primary_sponsor>
      <public_title>The effect of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients, A double – blind, randomized, placebo controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients, A double – blind, randomized, placebo controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/253</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>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Aloe vera jell powder 150 mg in capsule two times a day for two months. Intervention 2: Aloe vera jell powder 300 mg in capsule two times a day for two months. Intervention 3: placebo 150 mg in capsule two times a day for two months. Intervention 4: placebo 300 mg in capsule two times a day for two months.</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>Fallah Huseini Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahad daneshgahi research society, Kavosh Research town, Tehran-Qazvin Highway</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31375369</zip>
        <telephone>+98 261476401019</telephone>
        <email>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, Kavosh Research town, 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>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age between 40 to 60 years, 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%, singing the written informed consent. &#13;
&#13;
Exclusion criteria: insulin therapy, infectious diseases, severe kidney, liver, heart, or pulmonary disease, hypersensitivity to any drug, foot ulcer or gangrene, major depressive disorders, previous myocardial infarction, active cancer or previous cancer during the last 5 years, alcohol consumption, cigarette smoking, pregnancy, and 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>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Aloe vera jell powder 150 mg in capsule two times a day for two months</i_keyword>
      <i_keyword>Aloe vera jell powder 300 mg in capsule two times a day for two months</i_keyword>
      <i_keyword>placebo 150 mg in capsule two times a day for two months</i_keyword>
      <i_keyword>placebo 300 mg in capsule two times a day for two months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Baseline and after one and two months. Method of measurement: Glucose oxidase method.</prim_outcome>
      <prim_outcome>Glycosylated hemoglobin. Timepoint: Baseline and after two months. Method of measurement: HPLC method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>SGOT. Timepoint: Baseline and after two months. Method of measurement: SGOT level in fasting blood sample by DGKG enzymatic method.</sec_outcome>
      <sec_outcome>SGPT. Timepoint: Baseline and after two months. Method of measurement: SGPT level in fasting blood sample by DGKG enzymatic method.</sec_outcome>
      <sec_outcome>Creatinin. Timepoint: Baseline and after two months. Method of measurement: The fasting blood Creatinin level by JAPH enzymatic method.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: Baseline and after two months. Method of measurement: Fasting blood Cholesterol level by enzymatic oxidase method.</sec_outcome>
      <sec_outcome>LDL. Timepoint: Baseline and after two months. Method of measurement: Fasting blood LDL level by CDC designated comparison method.</sec_outcome>
      <sec_outcome>HDL. Timepoint: Baseline and after two months. Method of measurement: Fasting blood HDL level by enzymatic oxidase method.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Baseline and after two months. Method of measurement: Fasting blood Triglyceride level by  enzymatic oxidase method.</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>Jahad Daneshgahi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Avicenna Research Institute of  Academic Center for Education Culture</contact_name>
        <contact_address>Shaheed Beheshti University, Shaheed Chamran Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
