<?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>IRCT2014112820132N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-15</date_registration>
      <primary_sponsor>Shahid Sadooghi University of Medical Sciences and Health</primary_sponsor>
      <public_title>Effect of Chamomile tea consumption in the treatment of depressed patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of chamomile tea on depression status,  glycemic control, Blood lipid profiles and oxidative stress  in depressed patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17864</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive daily 3 cups of Chamomile tea at least half an hour after the meal for 12 weeks( each cup of Chamomile tea is produced by putting Chamomile tea bag contains 2.5 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 4 weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews. Intervention 2: control group 3 cups of black tea daily the same period (each cup of black tea is produced by putting black tea bag contains 2.5 grams in 150 cc of boiled water at least half an hour after eating the meal).</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>Prof. Hassan Mozaffari Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza integrated, Blvd student, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3624 0691</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Shahid Sadooghi University of Medical Sciences and Health Services in Yazd</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Hassan Mozaffari Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza integrated, Blvd student, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3624 0691</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Those aged between 60-30 years with mild to moderate depression (Beck test score of 30-11). no disorders and diseases of the kidney, liver, heart, thyroid, bleeding disorders and malignancies, autoimmune diseases, and degenerative diseases of the central nervous system as the express themselves, no history of hospitalization for mental illness, not using nutritional and antioxidant supplementation and sedative and diuretics during the last 3 months, diabetes mellitus type 2 (minimum 5 and maximum 15-year history of diabetes), and usage of blood glucose lowering drugs, patients with dyslipidemia who the usual treatment continue, Pregnant and lactating absence and lack of events such as job loss, divorce or death of their relatives during the last 3 months. Exclusion criteria: having allergy to chamomile, major depression (Beck test score greater than 30), which requires special treatment, , people that during the interview noticed Thoughts of suicide, self-injury and a history of such  in them and preferring not to drink tea.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32, F33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depressive episode, Recurrent depressive disorder</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 at least half an hour after the meal for 12 weeks( each cup of Chamomile tea is produced by putting Chamomile tea bag contains 2.5 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 4 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 of black tea daily the same period (each cup of black tea is produced by putting black tea bag contains 2.5 grams in 150 cc of boiled water at least half an hour after eating the meal)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Baseline, after 6 weeks of intervention and At the end of the intervention. Method of measurement: Beck Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>HbA1c. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Chromatography.</sec_outcome>
      <sec_outcome>LDL_C. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Freidwald’s formula.</sec_outcome>
      <sec_outcome>HDL_C. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Colorimetry.</sec_outcome>
      <sec_outcome>TG. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Colorimetry.</sec_outcome>
      <sec_outcome>TC. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Colorimetry.</sec_outcome>
      <sec_outcome>TAC. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Reduction DPPH.</sec_outcome>
      <sec_outcome>MDA. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Thiobarbituric Acid.</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>Shahid Sadooghi University of Medical Sciences and Health</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-16</approval_date>
        <contact_name>Ethics Committee of Shahid Sadooghi University of Medical Sciences and Health Services in Yazd, Iran</contact_name>
        <contact_address>Educational Research Center, Imam Reza, Next to the Governor, Daneshjo BLV Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
