<?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>IRCT2013012712299N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-05</date_registration>
      <primary_sponsor>Nutritional Research Center of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Chamomile tea consumption  in the treatment of patients with Type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Chamomile tea consumption  on  metabolic status, oxidative stress and inflammation in Type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12388</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random allocation method is Block randomization.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group  will receive daily 3 cups of Chamomile tea immediately after the meal for 8 weeks( each cup of Chamomile tea is produced by putting Chamomile tea bag contains 3 grams in 150 cc of boiled water).chamomile tea bags will be purchased from the Iranian  Institute of Medicinal Plants. All the patients will receive the Tea bags on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews. Intervention 2: control group 3 cups lukewarm boiled water daily over the same period (per cup after meal consumption).</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>Maryam Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 2295</telephone>
        <email>maryam.zemestani@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 2295</telephone>
        <email>maryam.zemestani@yahoo.com</email>
        <affiliation>Tabriz University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Type 2 diabetes for at least 6 months, age between 30-60 years, usage of blood glucose lowering drugs&#13;
 Exclusion criteria: usage of nutritional supplements in the past 3 months or during the study, usage of insulin, Pregnancy or lactation, BMI more than 37, Renal failure, liver disease, Cardiovascular disease, thyroid disorders, History of allergy, smoking, alcohol usage, Following a specific diet, Taking corticosteroids or immunosuppressive drugs</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10,E11,E1</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group  will receive daily 3 cups of Chamomile tea immediately after the meal for 8 weeks( each cup of Chamomile tea is produced by putting Chamomile tea bag contains 3 grams in 150 cc of boiled water).chamomile tea bags will be purchased from the Iranian  Institute of Medicinal Plants. All the patients will receive the Tea bags on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews</i_keyword>
      <i_keyword>control group 3 cups lukewarm boiled water daily over the same period (per cup after meal consumption)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic colorimetric.</prim_outcome>
      <prim_outcome>Fasting insulin serum. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA assay.</prim_outcome>
      <prim_outcome>HbA1C (Glycosilated hemoglobin). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: HOMA-IR calculation.</prim_outcome>
      <prim_outcome>Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).</prim_outcome>
      <prim_outcome>Serum malondialdehyde(MDA). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.</prim_outcome>
      <prim_outcome>Serum total antioxidant capacity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.</prim_outcome>
      <prim_outcome>GPX activity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.</prim_outcome>
      <prim_outcome>SOD activity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.</prim_outcome>
      <prim_outcome>Catalase enzyme activity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.</prim_outcome>
      <prim_outcome>Hc-CRP. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: immunoturbidimetry.</prim_outcome>
      <prim_outcome>TNF-a. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Macronutrients intake. Timepoint: before and after 8 weeks intervention. Method of measurement: 24-h recall Questionnaire.</sec_outcome>
      <sec_outcome>Anthropometric index(weight  and Body Mass Index). Timepoint: before and after 8 weeks intervention. Method of measurement: Analogue scale for weight and weight(Kg)/Square  Height for body mass index.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for Research, Tabriz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Nutritional Research Center of Tabriz University of Medical Sciences</source_name>
      <source_name>Vice chancellor for Research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-20</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golbad Street, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
