<?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>IRCT20220512054829N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-04</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of jujube syrup with desloratadine on chronic urticaria</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of jujube compound herbal medicine containing jujube, coriander, fumaria, lentil and  chicory with desloratadine  on chronic urticaria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using the permuted block randomization method, so that first all 4 blocks containing two codes A and B are prepared (6 blocks), then random blocks are selected by placement using a random number table. These blocks form a sequence of codes A and B equal to the sample size, and each code is randomly assigned to one of the groups. All randomization steps will be performed on the site https://ctrandomization.cancer.gov and using the Clinical Trial Randomization Tool option. The list of relevant codes will remain in the formulation department of Barij Essence Pharmaceutical Company until the completion of the project. This method will provide both blinding and randomization, Blinding description: The herbal syrup under study is manufactured in the formulation department of Barij Essans Pharmaceutical Company and is identical to Desloratadine (Neotadine) syrup (manufactured by Adora Teb Iran Company) in terms of appearance, size, and color of the glass and is provided in identical packaging. Then, it is coded based on codes previously prepared using a random number table and block randomization method. And it is provided to the project implementers in a mixed form in a carton.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic urticaria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Recipients of jujube syrup manufactured by Barij Essence Pharmaceutical Company, containing jujube, chicory, horsetail, lentils and coriander extracts, 10 cc twice a day for one month. Intervention 2: Control group: Recipients of desloratadine syrup manufactured by Iran Darou Pharmaceutical Company, 10 cc twice a day for one month.</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 Given that the sponsor of this study is a pharmaceutical company, it is necessary to obtain approval from the company and the university before publishing the study data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pezeshk Blvd, Ghotb Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973449</zip>
        <telephone>+98 31 5558 9396</telephone>
        <email>akbari1350_h@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Heidarzadeh Arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pezeshk Blvd, Ghotb Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973449</zip>
        <telephone>+98 31 5558 9396</telephone>
        <email>marz_heidar@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic urticaria with physician approval
Age between 12 and 65 years</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to desloratadine
Allergy to any of the ingredients in the herbal medicine jujube compound
Pregnancy
Severe angioedema
Having uncontrolled cardiovascular and respiratory diseases
Having uncontrolled hematological diseases
Having uncontrolled liver and kidney diseases
Having immune system diseases
Having connective tissue diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urticaria, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Recipients of jujube syrup manufactured by Barij Essence Pharmaceutical Company, containing jujube, chicory, horsetail, lentils and coriander extracts, 10 cc twice a day for one month.</i_keyword>
      <i_keyword>Control group: Recipients of desloratadine syrup manufactured by Iran Darou Pharmaceutical Company, 10 cc twice a day for one month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of hives. Timepoint: Before starting treatment and 7 and 14 and 28 days after starting treatment. Method of measurement: Urticaria Activity Score Questionnaire (UAS).</prim_outcome>
      <prim_outcome>Itching intensity. Timepoint: Before starting treatment and 7 and 14 and 28 days after starting treatment. Method of measurement: Urticaria Activity Score Questionnaire (UAS).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before starting treatment and 7 and 14  and 28 days after starting treatment. Method of measurement: Using the Chronic Urticaria Patients Quality of Life Questionnaire (CU-Q2OL).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: Before starting treatment and 7 and 14 and 28 days after starting treatment. Method of measurement: Urticaria Activity Score (UAS) questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Barij Essence Pharmaceutical Company</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kashan University of Medical Sciences</source_name>
      <source_name>Barij Essence Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-01</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing &amp; Midwifery, Health &amp; Paramedicine, Kashan</contact_name>
        <contact_address>Pezeshk Blvd, Ghotb Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
