<?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>IRCT2015081423426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-08</date_registration>
      <primary_sponsor>Bahram Mofid</primary_sponsor>
      <public_title>The effect of processed honey and royal jelly on cancer-related fatigue</public_title>
      <acronym>--</acronym>
      <scientific_title>Evaluation of the effect of processed honey and royal jelly on cancer-related fatigue: a double blind randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: randomization were done with using block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neoplasms.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 26 patients received processed honey and royal jelly. Processed honey and royal jelly, made under standard-state conditions with the permission of food and drug organization of ministry of health and medical education of Iran. The intervention group were instructed to consume their supplement 5mL twice daily for 4 weeks. They were assessd at the beginning of study, after 2 weeks, and then at the end of 4 weeks of treatment. Intervention 2: Control group : 26 patients received pure honey . Pure honey , made under standard-state conditions with the permission of food and drug organization of ministry of health and medical education of Iran. The control group were instructed to consume their supplement 5mL twice daily for 4 weeks. They were assessd at the beginning of study, after 2 weeks, and then at the end of 4 weeks of treatment.</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>Bahram Mofid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada-e-Tajrish Hospital, Department of Radiation Oncology</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2272 8081</telephone>
        <email>mofid429@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Shahram Yousefi Kashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada-e-Tajrish Hospital, Department of Radiation Oncology</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2271 5739</telephone>
        <email>shahpoo2002@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age more than 18; having the diagnosis of a solid (non-hematologic) malignancy; visual analogue scale (VAS) more than 4; Karnofsky Performance Status (KPS) more than 70; serum hemoglobin level of more than 8g/dL with no abrupt decrease (more than 2g/dl) during the last month; Liver enzymes not more than three times above the normal limits; serum total bilirubin less than 2mg/dL; serum creatinine less than 2mg/dL and creatinine clearance more than 60ml/mi. &#13;
Exclusion criteria: Patients with hypersensitivity to honey, uncontrolled cardiac or respiratory problems; any other serious medical condition, including severe infection or uncontrolled pain; pregnancy, major depression; taking medications with potential effects on fatigue; such as psychiatric medication (anti-depressants; psychostimulants,etc) or growth factors like erythropoietin.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C15, C16, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>---</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 26 patients received processed honey and royal jelly. Processed honey and royal jelly, made under standard-state conditions with the permission of food and drug organization of ministry of health and medical education of Iran. The intervention group were instructed to consume their supplement 5mL twice daily for 4 weeks. They were assessd at the beginning of study, after 2 weeks, and then at the end of 4 weeks of treatment.</i_keyword>
      <i_keyword>Control group : 26 patients received pure honey . Pure honey , made under standard-state conditions with the permission of food and drug organization of ministry of health and medical education of Iran. The control group were instructed to consume their supplement 5mL twice daily for 4 weeks. They were assessd at the beginning of study, after 2 weeks, and then at the end of 4 weeks of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cancer-related fatigue. Timepoint: Before intervention, 2 Weeks after intervention and 4 weeks after intervention. Method of measurement: Fatigue Severity Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>--. Timepoint: --. Method of measurement: --.</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>Bahram Mofid</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-08</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>2nd Shahid Beheshti University of Medical Sciences Bldg. ,Next to Ayatollah Taleghani Hospital, Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
