<?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>IRCT2016062720282N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-28</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acupuncture on hemodialysis pruritus</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Acupuncture ,as a complementary medicine,in controlling pruritus in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18018</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Renal failure  under Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Control Group:  Based on inclusion and exclusion criteria,patients are  selected.They fill consent and  questionnaires forms  then dermatologist does skin punch biopsy in the dorsal surface of the  hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist  through the draw of the parcel.Control group receive acupuncture by needling at 1 centimeter outside certain acupuncture point similar to intervention group, by expert, 2 times a week, for 6 weeks. After the last session of acupuncture, patients fill questionnaires again and  are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy. Intervention 2: Intervention group:  Based on inclusion and exclusion criteria,patients are  selected.They fill consent and  questionnaires forms  then dermatologist does skin punch biopsy in the dorsal surface of the  hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist  through the draw of the parcel. Intervention group receive acupuncture treatment by needling in the SP10, ST36, LI4, LV3, SP6 by experts 2 times a week, for 6 weeks .After the last session of acupuncture, patients fill questionnaires again and  are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy.</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>Shapour Badiee Aval</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Persian and Complementary Medicine</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3768 8519</telephone>
        <email>Badieeash@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ShapourBadiee Aval</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Persian and Complementary Medicine</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3768 8519</telephone>
        <email>Badieeash@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Main Inclusion criteria are:hemodialysis patients; older than 18 years and less than 65 years old; Itching for more than 3 months despite  recieving conventional therapy ;VAS scale score greater than 4;Under  Hemodialysis at least 6 months ;Be able to answer the questions.&#13;
Main Exclusion criteria are: Age less than 65 years or more than 18 years; history of bleeding or coagulation disorders;any history of skin disease,psychiatric disease,cancer,liver disease.;.No willing to continue acupuncture treatment during study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group:  Based on inclusion and exclusion criteria,patients are  selected.They fill consent and  questionnaires forms  then dermatologist does skin punch biopsy in the dorsal surface of the  hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist  through the draw of the parcel.Control group receive acupuncture by needling at 1 centimeter outside certain acupuncture point similar to intervention group, by expert, 2 times a week, for 6 weeks. After the last session of acupuncture, patients fill questionnaires again and  are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy.</i_keyword>
      <i_keyword>Intervention group:  Based on inclusion and exclusion criteria,patients are  selected.They fill consent and  questionnaires forms  then dermatologist does skin punch biopsy in the dorsal surface of the  hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist  through the draw of the parcel. Intervention group receive acupuncture treatment by needling in the SP10, ST36, LI4, LV3, SP6 by experts 2 times a week, for 6 weeks .After the last session of acupuncture, patients fill questionnaires again and  are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pruritus. Timepoint: before and after intervention. Method of measurement: VAS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mast cell infiltration. Timepoint: Before and  after intervention. Method of measurement: The number of mast cells per microscopic magnification 40 after Giemsa stain.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after. Method of measurement: Quality life questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-22</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah 16 Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
