<?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>IRCT2013021912525N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-16</date_registration>
      <primary_sponsor>Birjand Medical Sciences University, Vice Chancellor for Research</primary_sponsor>
      <public_title>The comparison of the effects of three therapeutic methods (oatmeal (Avena Sativa) , diluted vinegar sponge bath and Routine Protocol) in reducing uremic pruritus</public_title>
      <acronym></acronym>
      <scientific_title>Effects of three therapeutic methods (oatmeal (Avena Sativa) and diluted vinegar sponge bath and Routine Protocol) in reducing uremic pruritus in hemodialysis patients referred to the dialysis center of Birjand s’ Valiasr hospital - (2013)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Chronic kidney disease. Condition 2: pruritus.</hc_freetext>
      <i_freetext>Intervention 1: In the first group, patients will be treated by Avena lotion (made in Espanol company in Spain) twice per day for two weeks. After Wash out period  the second treatment period will be continued by diluted vinegar6%(30 ml vinegar/500ml water) twice per day for two weeks and after second Wash out period ,the subjects will receive routine protocol for two weeks. Intervention 2: In the second group, patients will be treated by diluted vinegar 6% (30 ml vinegar/500ml water) twice per day for two weeks. After Wash out period second treatment period will be continued by routine protocol for two weeks and after Wash out period, the subjects will receive Avena lotion (made in Espanol company in Spain) twice per day for two weeks. Intervention 3: In the third group, patients will be treated by routine protocol for two weeks. After Wash out period second treatment period will be continued by Avena lotion (made in Espanol company in Spain) twice per day for two weeks and after Wash out period ,the subjects will receive diluted vinegar 6%(30 ml vinegar/500ml water) twice per day for two weeks .</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>Samaneh Nakhaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gafari street, Birjand University of Medical Science, School of Nursing and Midwifery</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 1444 3041</telephone>
        <email>nakhaee67@bums.ac.ir;nakhaee38@yahoo.com</email>
        <affiliation>Birjand Medical Sciences University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ahmad Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gafari street, Birjand University of Medical Science, School of Nursing and Midwifery</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 1444 3041</telephone>
        <email>nasiri2006@bums.ac.ir</email>
        <affiliation>Birjand Medical Sciences University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Patients must be referred to the dialysis center of  Birjand Valiasr hospital؛ patients with renal failure (glomerular filtration rate less than60 ml/min for 3 months approved by a specialist)؛ with at least twice/ Tree times hemodialysis in week؛ they must be experienced Uremic pruritus at least for 2 weeks؛ They must be don’t have pruritus due to Dermal or non Dermal diseases.&#13;
&#13;
The absence of liver problems؛ Pregnancy and lactation؛ as well as acute inflammatory lesions of the skin؛ No known history of allergy were the other inclusion criteria.&#13;
&#13;
exclusion criteria:&#13;
&#13;
Unwillingness to continue participation in the study؛ Severe side effects like an allergic reaction to the vinegar or oats؛ Renal transplantation before end of therapy؛ Dyeing or emigration were identified as exclusion criteria.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
      <hc_code>L29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease</hc_keyword>
      <hc_keyword>Pruritus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group, patients will be treated by Avena lotion (made in Espanol company in Spain) twice per day for two weeks. After Wash out period  the second treatment period will be continued by diluted vinegar6%(30 ml vinegar/500ml water) twice per day for two weeks and after second Wash out period ,the subjects will receive routine protocol for two weeks.</i_keyword>
      <i_keyword>In the second group, patients will be treated by diluted vinegar 6% (30 ml vinegar/500ml water) twice per day for two weeks. After Wash out period second treatment period will be continued by routine protocol for two weeks and after Wash out period, the subjects will receive Avena lotion (made in Espanol company in Spain) twice per day for two weeks.</i_keyword>
      <i_keyword>In the third group, patients will be treated by routine protocol for two weeks. After Wash out period second treatment period will be continued by Avena lotion (made in Espanol company in Spain) twice per day for two weeks and after Wash out period ,the subjects will receive diluted vinegar 6%(30 ml vinegar/500ml water) twice per day for two weeks .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Uremic pruritus. Timepoint: Before and after each intervention and before dialysis. Method of measurement: Demographic checklist and pruritus questionnaire and Visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Birjand Medical Sciences University, Vice Chancellor for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-17</approval_date>
        <contact_name>Birjand Medical Sciences University ethics committee</contact_name>
        <contact_address>Gafari street, Birjand University of Medical Science Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
