<?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>IRCT2015061822806N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Iranian traditional medicine remedy on chemotherapy induced nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Iranian traditional medicine remedy compared  with placebo on resistant chemotherapy induced nausea and vomiting in breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: Random allocation and blinding was done this way: In the absence of research team, The laboratory expert, by using a computerized random number table,blindly allocated patients  to intervention or control groups for second session chemotherapy in study. Hereafter, drug package codes were determined for patients. In cross over, the expert announced drug packages codes to researcher for delivery to the patients. Thus, this study is a randomized and double-blind.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Nausea and vomiting. Condition 2: Breast cancer. Condition 3: Follow-up examination after chemotherapy for other conditions.</hc_freetext>
      <i_freetext>Intervention 1: 2.7 gram Persumac,plus one drop of black zirah essential oil made in Adonis Goldaroo,three time daily half hour before meal with one glass cold water. Intervention 2: 2.7 gram lactose, three time daily half hour before meal with one glass cold water.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>           ااا</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>Shokri, Sadegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bisim intersection, 6th jahad, opposite of Mehran gymnasium, Mashhad-Iran,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>shokris1@mums.ac.ir</email>
        <affiliation>school of Persian and Complementary medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazari, Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bisim intersection, 6th jahad, opposite of Mehran gymnasium, Mashhad-Iran,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>NazariM@mums.ac.ir</email>
        <affiliation>School of  Persian and Complementary medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 Female, Definitive diagnosis of breast cancer by oncologists and a pathology report by pathologist, Age&gt;18 years, History of chemotherapy induced nausea and vomiting resistant to conventional therapy, Normal tests for CBC, urea, creatinine, Alt, Ast, Bilirubin, FBS, Na, K, Have at least three sessions of chemotherapy ahead.&#13;
Exclusion criteria:&#13;
Total or upper abdominal radiation therapy along with chemotherapy- Taking anticoagulants, Use of other drugs/therapy for nausea and vomiting that not prescribed in this study, Hypersensitivity to Sumac or Bunium Persicum, Use of sumac and Bunium Persicum in seven days prior to the intervention, Diseases of the digestive system, Diseases that may associate with nausea and vomiting (such as hypertension, liver failure and kidney, digestive problems), Milk allergy, Losing of two consecutive or three intermittent doses of intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R-11</hc_code>
      <hc_code>C50.9</hc_code>
      <hc_code>Z09.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Breast, unspecified</hc_keyword>
      <hc_keyword>Follow-up examination after unspecified treatment for other conditions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>2.7 gram Persumac,plus one drop of black zirah essential oil made in Adonis Goldaroo,three time daily half hour before meal with one glass cold water.</i_keyword>
      <i_keyword>2.7 gram lactose, three time daily half hour before meal with one glass cold water</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of nausea in acute phase. Timepoint: Day 1 of intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Number of vomiting in acute phase. Timepoint: Day 1 of intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Severity of nausea in acute phase. Timepoint: Day 1 of intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Severity of vomiting in acute phase. Timepoint: Day 1 of intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency of nausea in delayed phase. Timepoint: day 2-5 of intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Frequency of vomiting in delayed phase. Timepoint: day 2-5 of intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Severity of nausea in delayed phase. Timepoint: day 2-5 of intervention. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Severity of vomiting in delayed phase. Timepoint: day 2-5 of intervention. Method of measurement: Visual Analog Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>TCTR20160401004</sec_id>
        <issuing_authority>Thai Clinical Trials Registry</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-07</approval_date>
        <contact_name>Medical ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University St., Ghoraishy Building Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
