<?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>IRCT20170305032883N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-09</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Probiotic and Cinnamomum in diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the simultaneus  effect of Probiotic  (Lactobacillus Acidufilus) and Cinnamomum on glycemic index, lipid profile, antioxidant and inflammatory parameters in diabetic type 2 patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25513</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization we use, block randomization and random numbers table.  
In this rule, eligible patients have been divided to blocks with4 or 6 members. 
We will get to half patients the numbers that first right digit of it, is even and to the others numbers that first right digit of it is odd,  in the random numbers table.Then we will get to the half of patients (who have even numbers) herbal drug and to the others (who have odd numbers) placebo. 
Place of randomization is the clinic. Herbal drug and placebo is packed in the same package, except performer of  Project, none has not information about it.
Total of sample is 120 and patients will use drug packages randomly, Blinding description: Randomization is double blind.The person who put drugs in the cans and tags on them, person who select eligible patients, person who block and specify drug and placebo and the physician and the patients  don’t know about contents.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Capsule content of 0.5gr Cinnamomum and 10^8 colony per unit Lactobacillus Acidufilus, orally for 90 days. Intervention 2: Intervention group2: Capsule content of 10^8 colony per unit Lactobacillus Acidufillus ,orally for 90 days. Intervention 3: Intervention group 3: One capsule orally per day content of 0.5gr cinnamomum powder. Intervention 4: Control group:Daily one capsule content of 0.5gr rice powder orally for 90 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>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 Due to the lack of completeness of information and data and the lack of clear results, there is still no definite program for publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahareh Tavakolifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical University, first Golestan, south Eshteraki, Baghestan, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3433 6007</telephone>
        <email>tavakkolifarb@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahareh Tavakolifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical University, first Golestan, south Eshteraki, Baghestan, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3433 6007</telephone>
        <email>tavakolifarb@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 25 to 65 years
Fasting blood sugar between 126 to 250 mg/dl
HbA1c less than 7.5</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are younger than 25 years old and older than 65 years old
People with severe diabetes (The blood sugar more than 250)
Women in pregnancy and lactation periods
People who consume special drugs (drugs which affect on blood sugar, such as corticosteroids, diuretics)
Usage insulin, vitamin supplements and herbal
Change in diabetes medicine during last 6 months
People who don't tolerate lactose
Patients who have artificial heart valve
Patients with short bowel syndrome
Patients with chronic liver , renal, lung, diseases and uncontrollable blood pressure
Patients with allergy
patients with special diet or physical activity
Diabetic type2 patients who need to use insulin</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Capsule content of 0.5gr Cinnamomum and 10^8 colony per unit Lactobacillus Acidufilus, orally for 90 days</i_keyword>
      <i_keyword>Intervention group2: Capsule content of 10^8 colony per unit Lactobacillus Acidufillus ,orally for 90 days</i_keyword>
      <i_keyword>Intervention group 3: One capsule orally per day content of 0.5gr cinnamomum powder</i_keyword>
      <i_keyword>Control group:Daily one capsule content of 0.5gr rice powder orally for 90 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar (FBS). Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: Glucometer.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Superoxide dismutase enzyme. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Glutathione  proxidase. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Catalase. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>OxLDL. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>AOPP. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: laboratory.</prim_outcome>
      <prim_outcome>AGEs. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: laboratory.</prim_outcome>
      <prim_outcome>FRAP. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: laboratory.</prim_outcome>
      <prim_outcome>TG. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Before intrvention and at the end of 3 month of begining. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>IL10. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>TNFα. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: kit.</prim_outcome>
      <prim_outcome>CRP. Timepoint: Before intrvention and at the end of 3 month of begining the research. Method of measurement: Laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects and liver toxicity. Timepoint: Within the reserch and until 1 month later. Method of measurement: Asking patients and observation if is needed.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-15</approval_date>
        <contact_name>Ethics committee of Pharmaceutical Sciences Branch, Islamic Azad University</contact_name>
        <contact_address>No. 99, Yasaman Alley, Yakhchal Street, Gholhak, Shariati Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-20</approval_date>
        <contact_name>Ethics committee of Alborz Univesity Of Medical Sciences</contact_name>
        <contact_address>Alborz Univesity Of Medical Science, above Taleghani square, Azimiyeh, Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
