<?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>IRCT20210404050833N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of herbal mixture in IBS</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of a mixture of plant extracts and placebo on the severity of symptoms in patients with irritable bowel syndrom: A randomized double blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on simple randomization, two series of numbers are obtained with the help of Random.org. Accordingly, patients who meet the conditions for entering the plan will be assigned to one of the two groups of treatment or placebo, respectively, Blinding description: Using exactly the same forms of syrup for medicine and placebo and installing the codes extracted from the random block table on them, the participants, the main researcher, the health care personnel (doctors, nurses, etc.) who are responsible for caring for the patients, Data collectors and those evaluating the outcome are completely blinded.</study_design>
      <phase>2</phase>
      <hc_freetext>Irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Individuals who met the inclusion criteria will take a drug formulated with a mixture of Echinophora platyloba, Trachyspermum copticum and Zataria multiflora  extracts, prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a month. Intervention 2: Control group: Individuals who met the inclusion criteria will take a placebo formulated without a mixture of plant extracts prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ramin Abrishami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 99, Yakhchal Ave , Gholhak , Shariati Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19395-6466</zip>
        <telephone>+98 21 2264 0051</telephone>
        <email>r_abrishami@iaups.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab sadat Tabaee Fazli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No.13, Shifte alley, after Hedayat square, Darus</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1943894471</zip>
        <telephone>+98 21 2255 6336</telephone>
        <email>zeinabfazli96@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People in the age range of 18 to 65 years
Written informed consent
People with a definitive diagnosis of IBS based on the Rome Criteria</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any concomitant illness other than IBS
People who are allergic to Echinophora platyloba, Trachyspermum copticum and Zataria multiflora or other herbal medicines
People who have had a history of taking herbal medicines during the last 3 months
Pregnant and lactating lady</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome</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: Individuals who met the inclusion criteria will take a drug formulated with a mixture of Echinophora platyloba, Trachyspermum copticum and Zataria multiflora  extracts, prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a month.</i_keyword>
      <i_keyword>Control group: Individuals who met the inclusion criteria will take a placebo formulated without a mixture of plant extracts prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal pain. Timepoint: Before starting the intervention and one month after that. Method of measurement: Paitient severity score questionnaire.</prim_outcome>
      <prim_outcome>IBS severity score. Timepoint: Before starting the intervention and one month after that. Method of measurement: Paitient severity score questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blowing. Timepoint: Before starting the intervention and one month after that. Method of measurement: Paitient severity score questionnaire.</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>Yas Daru Knowledge base Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-31</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Pharmaceutical Sciences</contact_name>
        <contact_address>No.99 , at the beginning of Yakhchal Ave, Gholhak, Shariati Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
