<?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>IRCT20090317001774N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-19</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Study lipase inhibitor and Alpha-glucosidase inhibitor in control of weight in obese patient</public_title>
      <acronym></acronym>
      <scientific_title>Study on the effects of co-administration of lipase inhibitor and Alpha-glucosidase inhibitor in control of weight in obese patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1352</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining consent, the patients are divided into three groups based on entering the study and the method of balanced block randomization with triple blocks. The first group received orlistat (three daily food supplements, 180 mg), the second group was orlistat-acarbose (orlistat 60 mg three times daily with food, 25 mg acarbose three times daily at the start of meal) and the group Control (multivitamin, weekly 1), Blinding description: The blinding of groups is divided by the expert of the research center which is not involved in the implementation of the plan, and is kept in the dark envelope in the package until the end of the design and final analysis at the research center. According to the traditional use group, there is no possibility of blindness for the physician and the patient. But randomization is done in the form of a balanced block randomization in binary groups and four blocks, and the statistician is blind compared to the groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: . Condition 2: obesity.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: The recipient of Orlistat (three daily food supplements, 180 mg) for 6 months. Intervention 2: Second Intervention group: The recipient of Orlistat and Acarbose (Orlistate 60mg 3 times daily with food, 25mg acarbose three times daily at the start of meal) for 6 months. Intervention 3: Control group: placebo (Multivitamin, weekly 1) for 6 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>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 Decision after the completing of study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Ehsan Aali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghazvin University of Medical Sciences - Shahid Bahonar Blvd. - Qazvin - Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34199-15315</zip>
        <telephone>+98 28333360015</telephone>
        <email>e.aali@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mojgan Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afzalipour Hospital, Kerman</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34313280003</telephone>
        <email>mjnsanjari@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20 to 50 years
Lack of underlying illness
BMI&gt;30</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fasting Blood Glucose Over 250
Hemoglobin A1C higher than 9%
Insulin therapy
Chronic inflammatory disease
Chronic complications of diabetes
Pregnancy
Lactation
Liver Diseases
Kidney Diseases
Neurological diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: The recipient of Orlistat (three daily food supplements, 180 mg) for 6 months</i_keyword>
      <i_keyword>Second Intervention group: The recipient of Orlistat and Acarbose (Orlistate 60mg 3 times daily with food, 25mg acarbose three times daily at the start of meal) for 6 months</i_keyword>
      <i_keyword>Control group: placebo (Multivitamin, weekly 1) for 6 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood glucose after 8 hours of fasting. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Measuring low density lipoprotein in serum. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Using an auto-analyzer method.</prim_outcome>
      <prim_outcome>Measuring high density lipoprotein in serum. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Using an auto-analyzer method.</prim_outcome>
      <prim_outcome>Measuring blood cholesterol. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Using an auto-analyzer method.</prim_outcome>
      <prim_outcome>Measuring blood triglycerides. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Using an auto-analyzer method.</prim_outcome>
      <prim_outcome>Insulin measurement. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Using ELISA test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Scales.</sec_outcome>
      <sec_outcome>Height. Timepoint: Before intervention and 6 months after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Waist. Timepoint: Before intervention and 6 months after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before intervention and 6 months after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>BMI. Timepoint: Before intervention and 6 months after intervention. Method of measurement: The squared height is divided by weight.</sec_outcome>
      <sec_outcome>WHR. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Computing.</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>2017-03-13</approval_date>
        <contact_name>Ethics Committee Vice chancellor for Research and Technology of kerman university of medical scienc</contact_name>
        <contact_address>Kerman, Vice chancellor for Research and Technology of University of Medical Sciences, Tahmasb Abad crossroads, the begining of Jahad Boulevard, the begining of Ebn-e-Sina street, In front of Besat clinic kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
