<?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>IRCT20090317001774N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-20</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of gel and aqueous extract of citrullus Colocynthis in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of gel and aqueous extract of Citrullus colocynthis (L.) Schrad in patients with type 2 diabetes compared to placebo gel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining patient's consent, the patients were classified into three groups according to inclusions criteria for study and balanced block randomization with triplex blocks. In one group, the appropriate amount of formulated gel in carboxymethyl cellulose (5%) is rubbed on the forearm with area 20 cm2 per day for 30 min. In the second group, the aqueous extract is used in a traditional method and the third group receives the placebo, Blinding description: For blinded-experiment, the groups are classified by the Research Center's expert that is not involved in the implementation of the project. This category preserved in the dark package envelope until the end of the design and final analysis at the research center. According to the traditional method group, there is no possibility of blindness for the physician and the patient, but the statistician is blind to the groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The appropriate amount of formulated gel in carboxymethyl cellulose (5%) is rubbed on the forearm with area 20 cm2 per day for 30 min. Intervention 2: Intervention group: Use of aqueous extract in a traditional method. Intervention 3: Control group: Getting a Placebo.</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. 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 34 1322 2270</telephone>
        <email>msanjari@kmu.ac.ir</email>
        <affiliation>Kerman 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 34 1322 2270</telephone>
        <email>msanjari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Newly diagnosed type 2 diabetic patients according to  ADA-2011 criteria
Cases between the age group of 18-75 years
Treated with oral medication (Metformin)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetic patients with fasting blood glucose greater than 250 mg/dL and hemoglobin A1C level higher than 9%
Treatment with insulin
Chronic inflammatory disease
Chronic complications of diabetes
Pregnancy
Breastfeeding
Liver, kidney and neurologic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The appropriate amount of formulated gel in carboxymethyl cellulose (5%) is rubbed on the forearm with area 20 cm2 per day for 30 min.</i_keyword>
      <i_keyword>Intervention group: Use of aqueous extract in a traditional method</i_keyword>
      <i_keyword>Control group: Getting a Placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient's blood glucose 2 hours after breakfast. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>HbA1c measurement. Timepoint: 0-90 days after start of the intervention. Method of measurement: Chromatography- %-=چ.</prim_outcome>
      <prim_outcome>Measurement of serum urea in fasting state. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>Measurement of serum creatinine level in fasting state. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>Measurement of aspartate aminotransferase in serum. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>Measurement of Alanine Transferase Level in Serum. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>Measurement of alkaline phosphatase in serum. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
      <prim_outcome>Measurement of bilirubin in patient serum. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-Calorie meter.</prim_outcome>
      <prim_outcome>Prothrombin time. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Seconds - Serology.</prim_outcome>
      <prim_outcome>Partial thromboplastin time. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Seconds - Serology.</prim_outcome>
      <prim_outcome>Blood glucose after 8 hours of fasting. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: mg/dl-spectrophotometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Barometer.</sec_outcome>
      <sec_outcome>Waist. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Medicinal effects. Timepoint: 0-30-60-90 days after start of the intervention. Method of measurement: Questionnaire.</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>2017-12-11</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
