<?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>IRCT20220818055740N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-28</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Title : Clinical evaluation of the effect of the combination of herbal cream containing Rosmarinus officinalis, , Malva sylvestris, Foeniculum vulgare extract and Oenothera biennis and Bitter Almond Oil for treatment of hair loos on patients with Areata Alopecia</public_title>
      <acronym></acronym>
      <scientific_title>Title : Clinical evaluation of the effect of the combination of herbal cream containing Rosmarinus officinalis, , Malva sylvestris, Foeniculum vulgare extract and Oenothera biennis and Bitter Almond Oil for treatment of hair loos on patients with Areata Alopecia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67348</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were 150 patients and were selected by simple random sampling  and Random assignment or random placement that is an experimental technique for assigning human participants or animal subjects to different groups in an experiment (e.g., a treatment group versus a control group) using randomization, such as by a chance procedure (e.g., flipping a coin). This ensures that each participant or subject has an equal chance of being placed in any group. Moreover, grouping of samples has been done using Randomizer(RA) software. Patients were divided into 6 groups of 25. For each treated group, a control group (triamcinolone cream) was placed separately, and the entrance of patients into these groups is random. Grouping of samples has been done using RA software. The blinding of this research is on behalf of the patient and the drug distributor. The homogenization of the studied groups is based on the variables: sex, age, type of alopecia areata and severity of hair loss in the head area. In general, randomization of patients was done based on coding, Blinding description: The single blindness of the study was performed in this process that at first the mentioned drugs received code without any labels and the patient selected one of the two drugs randomly. Then, the name of each person and the drug code provided to him registered by the secretary. Neither the patient nor the doctor was not aware of the type of medication.  The name of each person and his drug was specified only during analyzing the data,  and completed the patients' information profile by mentioning the name of the drug received by them.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hair loss in patients with alopecia areata.</hc_freetext>
      <i_freetext>Intervention 1: IMen treated with minoxidil and herbal cream prepared daily and checked up by a doctor monthly- Women with alopecia areata (AA) who are treated with minoxidil and herbal cream prepared daily and checked-up by a doctor monthly. Intervention 2: - Men with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Men with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a doctor monthly.- Women with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Women with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a physician monthly.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The project needs  to complete.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>محمود رفیعیان</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 38 1334 6692</telephone>
        <email>rafieian@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmmod Rafieian Kopaye</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord - Kashani Street - Shahrekord Univercity of Medical Sciences</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>881571347</zip>
        <telephone>+98 38 1334 6692</telephone>
        <email>rafieian@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent for participation in the study
hair loos on patients with Areata Alopecia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having no satisfaction to participate in this study
Having no suffering from hair loos on patients with Areata Alopecia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(L80-L99)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>(L00-L99)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>IMen treated with minoxidil and herbal cream prepared daily and checked up by a doctor monthly- Women with alopecia areata (AA) who are treated with minoxidil and herbal cream prepared daily and checked-up by a doctor monthly</i_keyword>
      <i_keyword>- Men with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Men with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a doctor monthly.- Women with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Women with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a physician monthly</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Subjects under study are examined for the presence of hair loss in the target area (alopecia of the head area) based on the extent of loss (in cm2) and they are given a score from 0 to 10. The area of ​​the lesion below 10 square centimeters is determined and at the end of every month after the visit by a specialist doctor,  hairy and terminal regrowth (Based on its extent is checked by examination, measurement (counting the number of hairs visually) and comparison with photography, as well as by surveying the patient. Timepoint: Visit doctor monthly. Method of measurement: Physician examination and survey by questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Subjects under study are examined for the presence of hair loss in the target area (alopecia of the head area) based on the extent of loss (in cm2) and they are given a score from 0 to 10. The area of ​​the lesion below 10 square centimeters is determined and at the end of every month after the visit by a specialist doctor, hairy and terminal regrowth (Based on its extent is checked by examination, measurement (counting the number of hairs visually) and comparison with photography, as well as by surveying the patient. Timepoint: Monthly for 3 months. Method of measurement: Visit by doctor and survey by 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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-24</approval_date>
        <contact_name>Shahrekord Univercity of Medical Sciences</contact_name>
        <contact_address>Shahrekord - Kashani Street - Shahrekord Univercity of Medical Sciences Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
