<?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>IRCT20150706023084N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-21</date_registration>
      <primary_sponsor>Parmoon Salamat Amin Pharmaceutical Company</primary_sponsor>
      <public_title>Anaheal plus supplement in contact dermatitis</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the therapeutic effects of Anaheal plus supplement in patients with contact dermatitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: For all patients (both test group and control group), we prescribe the standard treatment that is moisturizing. In addition to the standard treatment, the test group also receives Anahil Plus supplement twice a day. The control group will receive a placebo instead of a supplement. After a month, we will re-examine the factors of the involvement level, redness, inflammation and itching, Randomization description: After the diagnosis of the disease by the dermatologist, using the rand number site, each patient was assigned a number, Blinding description: This study is conducted in single blind way, so that the patients are not aware of the contents of the received packages that contain Bremelin and Curcumin or placebo. Conventionally, the packages containing supplement number one and the packages containing placebo number two. We attribute Using rand number, we determine whether to give medicine or placebo to each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>Irritant contact dermatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: including 25 patients who are diagnosed with contact dermatitis by a dermatologist and consume Anahil Plus supplement produced by the company (two tablets daily) plus moisturizer as a standard treatment for 30 days. The questionnaire form is filled at the beginning and after one month. Intervention 2: Control group:includes 25 patients who are diagnosed with contact dermatitis by a dermatologist and use standard moisturizer as a treatment for 30 days along with a placebo containing lactose. The relevant questionnaire is filled at the beginning and 30 days later.</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:
Data are collected in the form of a questionnaire

When:
After the intervention

To whom:
Qualified persons

Conditions:
Used foe scientific advancement in the field under study

Where to obtain:
Clinical office of Islamic Azad University,Medical science of tehran, Faculty of pharmacy

How to obtain:
Request in writing by going through legal procedures.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shiehmorteza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.99, Yakhckal street, DR Shariati Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916893813</zip>
        <telephone>+98 21 2264 0056</telephone>
        <email>Shiehmorteza@iaups.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shiehmorteza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.99, Yakhchal street, Dr Shariati Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916893813</zip>
        <telephone>+98 21 2264 0056</telephone>
        <email>Shiehmorteza@iaups.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients (over 12 years old)
Patient with contact dermatitis</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to pineapple, celery, carrot and fennel
having hemophilia
taking two anti-platelet drugs or one anti-platelet drug and an anticoagulant
severe kidney failure (GFR&lt;30)
severe liver failure (Child pugh B, C)
Pregnancy
lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritant contact dermatitis, unspecified cause</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: including 25 patients who are diagnosed with contact dermatitis by a dermatologist and consume Anahil Plus supplement produced by the company (two tablets daily) plus moisturizer as a standard treatment for 30 days. The questionnaire form is filled at the beginning and after one month.</i_keyword>
      <i_keyword>Control group:includes 25 patients who are diagnosed with contact dermatitis by a dermatologist and use standard moisturizer as a treatment for 30 days along with a placebo containing lactose. The relevant questionnaire is filled at the beginning and 30 days later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The surface of the affected area. Timepoint: 30 days. Method of measurement: Measuring with a ruler.</prim_outcome>
      <prim_outcome>Redness. Timepoint: 30 days. Method of measurement: According to REEDA.</prim_outcome>
      <prim_outcome>Edema. Timepoint: 30 days. Method of measurement: According to REEDA.</prim_outcome>
      <prim_outcome>Itching. Timepoint: 30 days. Method of measurement: Ask the patient.</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>Parmoon Salamat Amin Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-24</approval_date>
        <contact_name>Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical</contact_name>
        <contact_address>Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
