<?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>IRCT20200825048515N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-18</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Manual Acupuncture on the Treatment of Allergic Rhinitis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Manual Acupuncture along with Conventional Therapies on the Treatment of Allergic Rhinitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will be randomly selected. Then, random numbers are generated and divided into two groups using computer random allocation software. A number will be randomly assigned to each patient; that this number indicates what group should be patient assigned.</study_design>
      <phase>3</phase>
      <hc_freetext>Allergic Rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For patients, in addition to conventional treatment, they will be treated with manual acupuncture twice a week for three weeks. Before starting the acupuncture treatment, patients will be examined to specify traditional Chinese medicine pattern recognition. Basic points for acupuncture including Tinghui (GB2, depth 0.5 cun), Tinggong (SI19, depth: 0.5cun), Ermen (TE21, depth 0.5cun), and Yifeng (TE17, depth 0,5cun ) will be selected according to the World Health Organization guidelines. Other points are selected according to guidelines on Chinese medicine diagnosis. A maximum of five points of the most active points will be selected by point selector devise. patients are placed in the sitting position and the acupoint area will be disinfected twice with iodine. The acupuncturist places his/her left index finger immediately above the acupoint, holds the needle between his/her right thumb and index finger, and quickly pierces the skin of the patient. Intervention 2: Intervention group: For patients, only the conventional treatment is performed. Conventional treatment for allergic rhinitis will include the use of 10 mg Cetirizine tablets daily, and the use of normal saline nasal spray to rinse the nose, as well as the daily Beconase spray inside each nose.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayed Mostafa Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983414</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>mostafa_hashemi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayed Mostafa Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983414</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>mostafa_hashemi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Allergic Rhinitis
Positive skin allergy test determined by Skin Prick Test (SPT)
Declaring satisfaction to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any previous rhinoplasty surgery
Having nasal anatomical abnormalities such as nasal polyps or septal abnormalities
Having a refractory asthma
Having a long-term use of corticosteroids
Having tuberculosis
Having diabetes, and any other chronic systemic diseases as well as being suspicious for malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J30.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Allergic rhinitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For patients, in addition to conventional treatment, they will be treated with manual acupuncture twice a week for three weeks. Before starting the acupuncture treatment, patients will be examined to specify traditional Chinese medicine pattern recognition. Basic points for acupuncture including Tinghui (GB2, depth 0.5 cun), Tinggong (SI19, depth: 0.5cun), Ermen (TE21, depth 0.5cun), and Yifeng (TE17, depth 0,5cun ) will be selected according to the World Health Organization guidelines. Other points are selected according to guidelines on Chinese medicine diagnosis. A maximum of five points of the most active points will be selected by point selector devise. patients are placed in the sitting position and the acupoint area will be disinfected twice with iodine. The acupuncturist places his/her left index finger immediately above the acupoint, holds the needle between his/her right thumb and index finger, and quickly pierces the skin of the patient.</i_keyword>
      <i_keyword>Intervention group: For patients, only the conventional treatment is performed. Conventional treatment for allergic rhinitis will include the use of 10 mg Cetirizine tablets daily, and the use of normal saline nasal spray to rinse the nose, as well as the daily Beconase spray inside each nose.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Runny nose. Timepoint: Based on Visual analog scale. Method of measurement: Before, 2 and 6 weeks after treatment.</prim_outcome>
      <prim_outcome>Sneezing. Timepoint: Before, 2 and 6 weeks after treatment. Method of measurement: Based on Visual analog scale.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-23</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
