<?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>IRCT20200408047000N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-04</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The impact of Florabile syrup on intensity of Psoriasis rashes.</public_title>
      <acronym></acronym>
      <scientific_title>The  impact of Florabile syrup on intensity (inflammation, plaque, and scaling) of Psoriasis rashes in patients aged 20 to 50 years.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47064</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This is a semiexperimental pre and post control study (self-control) which is going to be dine on patients with Psoriasis. The drug under study is available in market and is effective on liver disease treatments; this survey is to study the impact of this syrup on psoriasis. This is a kind of herbal medicine with no known side effects.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Psoriasis.</hc_freetext>
      <i_freetext>Experimental group: Consumer of Florabil syrup consisting:Tamarindus  indica, Prune's domestica, Prune's spinosa L, Ziziphus juijub mill, Cordia myxa, Prunus armeniaca, Manna; and the benefits of this syrup includes increasing bile flow and facilitate it to exit the body, cleansing and strengthening the liver, controlling liver heat, removing tongue and skin dryness. No specific side effects have been reported for this medicine. 25patients aged 20 to 50 years with mild to moderate Psoriasis participated the study for a 30 day experimental period; and they diluted Florabile Syrup from Farateb company of Yazd containing three spoons (each spoon with an approximate volume of 15cc) with a glass of water and consumed one hour before lunch daily..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Parts of data(Information about the consequences) allowed to be shared after making participants unknowable.

When:
Access time starts 6 months after printing the results.

To whom:
Dermatologists and complementary medicine specialist, researchers employed in academic and scientific institutions.

Conditions:
Only to help patients and for research purposes, any usage with citation.

Where to obtain:
Visiting Iranian Medicine Center at Amin hospital in Isfahan or email to : mahdavi88311388@gmail.com

How to obtain:
Email to mahdavi88311388@gmil.com and after sending the email, the data will be sent as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ameneh Parastegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 79, Kosar Alley, Pasdaran Street,West Baharestan Street, Imam Khomeini Street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195618888</zip>
        <telephone>+98 31 3324 3522</telephone>
        <email>mahdavi88311388@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mazaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Medicine Group, Amin Hospital, Ibn Sina Street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8148653141</zip>
        <telephone>+98 31 3447 4246</telephone>
        <email>Mazaherimohammad@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>The patient must be between 20 to 50 years old.
Patients should have mild to moderate Psoriasis and their body should be involved less than 20%.
If patient has taken any other drugs to treat Psoriasis, he or she should not consume new dug for three months.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with generalized, unstable, or pustular Psoriasis who have only skull, nails, flexor surfaces or palms and soles involvement.
Patients who are pregnant or breastfeeding.
Patients who are allergic to plums, jujube, and Tamarindus indica-derived products.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Psoriasis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: Consumer of Florabil syrup consisting:Tamarindus  indica, Prune's domestica, Prune's spinosa L, Ziziphus juijub mill, Cordia myxa, Prunus armeniaca, Manna; and the benefits of this syrup includes increasing bile flow and facilitate it to exit the body, cleansing and strengthening the liver, controlling liver heat, removing tongue and skin dryness. No specific side effects have been reported for this medicine. 25patients aged 20 to 50 years with mild to moderate Psoriasis participated the study for a 30 day experimental period; and they diluted Florabile Syrup from Farateb company of Yazd containing three spoons (each spoon with an approximate volume of 15cc) with a glass of water and consumed one hour before lunch daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Suitable (PASI; Psoriasis Area Severity Index) for any patient. Timepoint: At the beginning of the study (Before intervention) and after finishing the study. Method of measurement: The software of calculating Psoriasis Severity Area Index. Version 1.7.2.</prim_outcome>
      <prim_outcome>Percent of patients body surface involved (BSA; Body Surface Area). Timepoint: At the beginning of the study (Before intervention) and after finishing the study. Method of measurement: Calculating formula of the Percent of patients body surface involved.</prim_outcome>
      <prim_outcome>Erythema (redness) of Psoriasis rashes. Timepoint: At the beginning of the study (Before intervention) and after finishing the study. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Induration (plaque) of Psoriasis rashes. Timepoint: At the beginning of the study (Before intervention) and after finishing the study. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Desquamation (scaling) of Psoriasis rashes. Timepoint: At the beginning of the study (Before intervention) and after finishing the study. Method of measurement: Observation.</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>2019-03-13</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezarjerib Street. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
