<?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>IRCT2015050322060N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-16</date_registration>
      <primary_sponsor>Yousef Abdul-Latif Jameel Chair for Prophetic Medicine</primary_sponsor>
      <public_title>Wet cupping improve Quality of Life of Adult Patients Complaining from Chronic Medical Conditions in King Abdulaziz University</public_title>
      <acronym>Effect of cupping on QoL</acronym>
      <scientific_title>Effect of Wet cupping on Quality of Life of Adult Patients Complaining from Chronic Medical Conditions in King Abdulaziz University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19118</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: An intervention study with pre-test, intervention and post- tests were done at the Cupping Clinic, KAUH &#13;
Pre-test: Upon enrollment, all patients completed a validated, pre-constructed, self-administered, confidential questionnaire. The questionnaire will be used to collect personal and socio-demographic data as well as data about the reason for referral to the Cupping Clinic. They were requested to report the type of pain and other medical conditions. The HRQOL will be assessed using the WHOQOL- BREF before and after cupping. The WHOQOL-BREF contains 26 questions, two of which are general and 24 that assess four domains, namely physical health, psychological health, social relationships, and environmental domains. The internal consistency of the WHOQOL- BREF and the four domains of the questionnaire will be assessed and ranged from 0.66 – 0.925. The content validity, construct validity, and the reliability of the WHOQOL-BREF are good. 11,12 &#13;
Intervention: Wet cupping will be performed by an expert certified physicians who regularly performed cupping in the clinical settings. &#13;
Post-test: Patients completed the same questionnaire one month after cupping.  They were also asked about pain improvement after cupping, and if present when the felt the improved pain. &#13;
Outcome measures: Scoring of the various continuous HRQOL domains will be done according to the WHOQOL-BREF at the baseline and one month after cupping treatment.</study_design>
      <phase>4</phase>
      <hc_freetext>Chronic medical conditions.</hc_freetext>
      <i_freetext>Cupping clinic was approved by the Faculty and the University.&#13;
A clinical trial study (Quasi-experimental study) with pre-test, the intervention by cupping, and post-test was done..</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. Soad Al Jaouni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>King Abdulaziz University, Hematology Department, Faculty of Medicine,</address>
        <city>Jeddah</city>
        <country1>Saudi Arabia</country1>
        <zip>21551</zip>
        <telephone>00</telephone>
        <email>dr.jaouni@gmail.com</email>
        <affiliation>Yousef Abdul-Latif Jameel</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Nahla Ibrahim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>King Abdulaziz University</address>
        <city>Jeddah</city>
        <country1>Saudi Arabia</country1>
        <zip>21551</zip>
        <telephone>00</telephone>
        <email>nahlakhamis@yahoo.com</email>
        <affiliation>King Abdulaziz University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Saudi Arabia</country2>
      <country2>Saudi Arabia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: include all adult patients (18-60 years) referred for chronic conditions, fully understand the research process and willing to provide informed consent. &#13;
Exclusion criteria:&#13;
Patients will be excluded from the study if they were using medication on regular basis, if they  not willing to comply with the study protocol or if they had mental illnesses that interfere with completing the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIII</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue (M00-M99)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Cupping clinic was approved by the Faculty and the University.&#13;
A clinical trial study (Quasi-experimental study) with pre-test, the intervention by cupping, and post-test was done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scoring of the various continuous Health related Quality of Life (HRQOL ) domains  according to the WHOQOL-BREF at the baseline and one month after cupping treatment. R. Timepoint: After cupping, Post -test Scoring of the various continuous Health Related Quality of Life (HRQOL ) domains. Method of measurement: HRQOL WHO The WHOQOL-BREF contains 26 questions, two of which are general and 24 that assess four domains, namely physical health, psychological health, social relationships, and environmental domains.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improve general condition, decrease pain. Timepoint: After the wet cupping. Method of measurement: Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>Reference Number: 851-12</sec_id>
        <issuing_authority>Registration in the IRB</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yousef Abdul-Latif Jameel Chair for Prophetic Medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Institutional Review Board (IRB) of the Faculty of Medicine, King Abdulaziz Universty Hospital. The </contact_name>
        <contact_address>Faculty of Medicine, KAUH, and it was conformed to the ethical standards of the Helsinki Declaration. Jeddah Jamaa Saudi Arabia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
