<?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>IRCT20150706023084N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-22</date_registration>
      <primary_sponsor>Salamat Parmoon Amin Pharmaceutical company</primary_sponsor>
      <public_title>Anaheal plus effect on acne</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effects of Anaheal plus supplement on inflammation and scarring caused by acne</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70522</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the study, each patient is assigned a code (1 or 2) using Rand number. Conventionally, the patient who received code one will receive drug and the patient who received code two will receive placebo. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue, Blinding description: This study will be Single blinded in such a way that the participants will not be aware of the contents of the medicine package they receive. A code will be assigned to each patient using a Rand number. Patients whose code is 1 will receive the drug, and patients who are assigned a code of 2 will receive a placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Acne.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 25 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and receive A H A exfoliator once a day on the areas which have acne scars and also they will consume Anaheal Plus supplement which contains bromelain and curcumin and is produced by Salamat parmoon amin pharmaceutical Co. two times a day (One in the morning and one in the evening) for one month. Considered variables will be checked one month after the start of the treatment. Intervention 2: Control group:25 patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo capsule which is produced by Salamat parmoon amin pharmaceutical Co.  twice a day for one month instead of Anaheal plus.</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 for 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, Yakhchal street, Dr Shariati Ave.</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 Ave, Dr Shariati</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۱۶۸۹۳۸۱۳</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>Acne scarring
Age range over 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to pineapple, curcuma, celery, carrot and  fennel
Pregnancy
Lactation
Renal failure (GFR&lt;30)
liver failure (Child pugh B,C)
Hemophillia
Using two antiplatelet drug
Using one anti platelet and one  anti coagulant drug</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acne</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: 25 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and receive A H A exfoliator once a day on the areas which have acne scars and also they will consume Anaheal Plus supplement which contains bromelain and curcumin and is produced by Salamat parmoon amin pharmaceutical Co. two times a day (One in the morning and one in the evening) for one month. Considered variables will be checked one month after the start of the treatment.</i_keyword>
      <i_keyword>Control group:25 patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo capsule which is produced by Salamat parmoon amin pharmaceutical Co.  twice a day for one month instead of Anaheal plus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of lesions caused by acne scars. Timepoint: 30 days. Method of measurement: Observational.</prim_outcome>
      <prim_outcome>Area of scar caused by acne. Timepoint: 30 days. Method of measurement: Measure with a ruler.</prim_outcome>
      <prim_outcome>Inflammation. Timepoint: 30 days. Method of measurement: According to dermatologist opinion.</prim_outcome>
      <prim_outcome>Redness. Timepoint: 30 days. Method of measurement: According to dermatologist opinion.</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>Salamat Parmoon 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>
