<?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>IRCT20180923041093N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-12</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mango leaf on diabetes on lipid profiles</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Mangifera indica extract supplement on metabolic status in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By random allocation software, Blinding description: Drug coding will be done by a third party and during the study, not everyone, including physicians, patients, and those responsible for drug delivery will be aware of the type of drug used and the placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mango leaf extract 500 mg, twice daily, for 45 days. Intervention 2: Control group: Placebo 500 mg twice daily for 45 days.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After the completion of the study, the information on the main outcome will be shared.

When:
10 months after printing

To whom:
All researchers can take action.

Conditions:
Data and results will be available to all researchers for research on diabetes.

Where to obtain:
To email: hashemifa67@gmail.com

How to obtain:
The data will be provided to the applicant after a review and approval of the request within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad Amir kabir, jomhuri eslami Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>dr.azimm@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad Amir kabir, jomhuri eslami Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0860</telephone>
        <email>dr.azimm@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 1 Diabetes According to the World Health Organization's online guide from 6 months ago
Taking blood sugar lowering drugs</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Changes in diabetes medications from 2 months before the study
Insulin consumption
Smoking
Pregnancy
Use of herbal medications
Lactation
Gastrointestinal and liver problems
Hormonal problems such as thyroid dysfunction
Cardiac problems
Medications that interfere with blood sugar and lipid levels such as non-inflammatory drugs Steroid</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mango leaf extract 500 mg, twice daily, for 45 days</i_keyword>
      <i_keyword>Control group: Placebo 500 mg twice daily for 45 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting serum Glucose concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>2 hours post prandial. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting serum Glucose concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Fasting Insulin. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting serum Insulin concentration in µU/ml by kit.</prim_outcome>
      <prim_outcome>Serum Teriglycerid. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting serum Teriglycerid concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Serum cholestrol. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting Serum cholestrol concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>LDL Cholestrol. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl, calculating by Friedewald formula.</prim_outcome>
      <prim_outcome>HDL Cholestrol. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl by kit.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Baseline and 45 days after the intervention. Method of measurement: Weight to square height ratio.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-21</approval_date>
        <contact_name>Research ethic committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
