<?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>IRCT2013082814505N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-07</date_registration>
      <primary_sponsor>Birjand University of Medical Sceinces</primary_sponsor>
      <public_title>The Effect of Herbal Formulation (Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark) on the Amount and Intensity of Tinnitus, randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Herbal Formulation (Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark) on the Amount and Intensity of Tinnitus, randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14125</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tinnitus.</hc_freetext>
      <i_freetext>Intervention 1: Group A: receiving Cinnarizine, after randomization we gave to patients Cinnarizine tablets of 25 mg (manufactured by Osve Company). If patients who had failed to respond effectively, (THI&gt;30) intervention was extended for another 28 days. Data collection was based on THI and VAS criteria before 28 and 56 days after intervention. Intervention 2: Group B: receiving herbal formulation (Salvia hydrange, Citrus aurantium, Lipiacitriodora, and Elmbark), ), formulation in sealed packages (4 g of each herb and 12 g of elmbark) with a cup and recipe of herbal tea (5 g of powder of the mixed herbs in a cup of boiled water three times a day before each meal). Data collection was based on THI and VAS criteria before 28 and 56 days after intervention. Intervention 3: placebo in the form of gelatin capsules containing starch was prescribed for 28 days.</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>Mansour Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences, Ghafari Avenue, Birjand, South Khorasan, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3244 3044</telephone>
        <email>msoltani.msc@bums.ac.ir</email>
        <affiliation>Paramedic Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghasem Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences, Ghafari Avenue, Birjand, South Khorasan, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3244 3042</telephone>
        <email>ghasemkarimi@bums.ac.ir</email>
        <affiliation>Medical Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: giving consent to participate in the study, having an age of 17-70 years old, and suffering from tinnitus for more than 4 months.&#13;
Exclusion criteria: otitis media, ear tumor, deformity within the ear; ototoxic drugs like gentamicin; ear surgery, pregnancy, breastfeeding or taking birth control pills, extensive surgery or blood transfusion during the previous month, kidney failure, history of stroke or thyroid disease, Otosclerosis, addiction to drugs or alcohol; occupational exposure to noise</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H83.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Noise Effects On Inner Ear</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A: receiving Cinnarizine, after randomization we gave to patients Cinnarizine tablets of 25 mg (manufactured by Osve Company). If patients who had failed to respond effectively, (THI&gt;30) intervention was extended for another 28 days. Data collection was based on THI and VAS criteria before 28 and 56 days after intervention.</i_keyword>
      <i_keyword>Group B: receiving herbal formulation (Salvia hydrange, Citrus aurantium, Lipiacitriodora, and Elmbark), ), formulation in sealed packages (4 g of each herb and 12 g of elmbark) with a cup and recipe of herbal tea (5 g of powder of the mixed herbs in a cup of boiled water three times a day before each meal). Data collection was based on THI and VAS criteria before 28 and 56 days after intervention.</i_keyword>
      <i_keyword>placebo in the form of gelatin capsules containing starch was prescribed for 28 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tinnitus Severity. Timepoint: Following at first, one month and if it was needed 2 month later. Method of measurement: Phisical Examination, Audiometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Failure Criterion of Tinnitus. Timepoint: َAt First and One Month Later. Method of measurement: THI &amp; VAS Scales.</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 University of Medical Sceinces</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-01</approval_date>
        <contact_name>Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghafari Avenue, Birjand, South Khorasan, Iran Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
