<?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>IRCT20101130005280N46</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of acupuncture on chronic prostatitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of acupuncture on treatment in patients with chronic nonbacterial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61786</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is how random numbers are prepared with the help of Randomaize.com. According to the number of research samples, a number of envelopes with wrappers
Alumni (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the random sequences created on a card is recorded and the cards inside the envelopes are better named. In order to maintain a random sequence, also on the outer surface of the envelopes.
The issuance number is done in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively.
At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the envelopes have the odd number of the control group and the envelopes have an even number, Blinding description: People under study and outcome assessor are fully aware of the subject of research and the purpose and process of the study, and after filling out the consent and according to the entry conditions, will enter the study of the contents of the envelope and to which group they are assigned (control and intervention) (Because they do not predict the outcome) will be unaware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic prostatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In the intervention group, in addition to the usual treatments (1. One tamsulosin capsule per night 2. Naproxen 251 mg tablets every 02 hours 3. Toltorudine 2 mg ER per night), the patients also receive acupuncture treatments (10 sessions a day in between). Intervention 2: Control group: Individuals in the control group receive routine care (therapeutic, educational, etc.) (1. One tamsulosin capsule per night 2. Naproxen 251 mg tablets every 02 hours 3. Toltorudine 2 mg ER per night).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is After finishing work, consult with colleagues and it will be published if all members</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Salman Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, University Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13944-91388</zip>
        <telephone>38795031 051</telephone>
        <email>SoltaniS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Salman Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, University Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>38795031 051</telephone>
        <email>SoltaniS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 50 years
NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score ≥15
Pelvic pain and urinary symptoms lasting at least 3 to 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Prostate surgery
Taking certain medications that may react to acupuncture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic prostatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the intervention group, in addition to the usual treatments (1. One tamsulosin capsule per night 2. Naproxen 251 mg tablets every 02 hours 3. Toltorudine 2 mg ER per night), the patients also receive acupuncture treatments (10 sessions a day in between).</i_keyword>
      <i_keyword>Control group: Individuals in the control group receive routine care (therapeutic, educational, etc.) (1. One tamsulosin capsule per night 2. Naproxen 251 mg tablets every 02 hours 3. Toltorudine 2 mg ER per night)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perineal anal pain sometimes in the buttocks and groin. Timepoint: Beginning and end of the intervention. Method of measurement: Using the International Prostate Symptom Score and The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaires will be evaluated and the results before and after treatment will be compared.</prim_outcome>
      <prim_outcome>Tingling and tingling in the legs. Timepoint: Beginning and end of the intervention. Method of measurement: Using the International Prostate Symptom Score and The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaires will be evaluated and the results before and after treatment will be compared.</prim_outcome>
      <prim_outcome>Pain in the testicles. Timepoint: Pain in the testicles. Method of measurement: The use of international prostate symptom score questionnaires and The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) will be evaluated and the results before and after treatment will be compared.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-23</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Science</contact_name>
        <contact_address>Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
