<?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>IRCT20220603055066N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-28</date_registration>
      <primary_sponsor>Bam University of Medical Sciences</primary_sponsor>
      <public_title>Comparative evaluation of PRP with nutritional supplements in improvement of hair loss  in patients recovered from COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of PRP (Platelet-Rich Plasma) with nutritional supplements in improvement of hair loss (telogen effluvium) in patients recovered from COVID-19 in Bam Pasteur hospital in 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63995</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>telogen effluvium.</hc_freetext>
      <i_freetext>Intervention 1: Therapeutic intervention in the first group includes nutritional supplements (folic acid, vitamin D, zincplus and hair vit.) which are prescribed to the person daily for three months based on daily needs and BMI. Intervention 2: The therapeutic intervention in the second group includes PRP injection once every three weeks and for four sessions. It should be noted that PRP is used autologously and from the patient's own blood product, and the obtained PRP is used only for the patient himself. In this way, 20 ml of the person's venous blood is introduced by a trained nurse in a tube containing sodium citrate and centrifuged for five minutes at a speed of 1500 rpm. Using a sterile syringe, the plasma is transferred to a tube without anticoagulants by a trained nurse and placed in a second centrifuge at 2500 rpm for 20 minutes.The resulting PRP is then collected. Each time PRP is injected intradermally at a dose of 0.1-0.2 ml per injection at a distance of about one centimeter in the interfollicular areas of the frontal and vertebral region by a dermatologist.</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>Sahar ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Alley 3, Seyed Al-Shohada Boulevard</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7661777997</zip>
        <telephone>+98 34 4431 1921</telephone>
        <email>faezebahadornia@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Alley 3, Seyed Al-Shohada Boulevard</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7661777997</zip>
        <telephone>+98 34 4431 1921</telephone>
        <email>faezabahadornia@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20 to 50 years
Covid 19 disease (positive by PCR test) 2 to 4 months before enrollment
Occurrence of persistent and significant hair loss after Covid 19 disease, which according to the diagnosis of a dermatologist has a pattern similar to telogen effluvium</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are diagnosed as the other types of alopecia (except telogen effluvium)
Pregnant or lactating women
Patients who are being treated with drugs such as finasteride, spironolactone, minoxidil or OCP or who have recently stopped taking these drugs
Patients who have an underlying disease affecting hair loss
Lack of informed consent to enter the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L65.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Telogen effluvium</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>Therapeutic intervention in the first group includes nutritional supplements (folic acid, vitamin D, zincplus and hair vit.) which are prescribed to the person daily for three months based on daily needs and BMI.</i_keyword>
      <i_keyword>The therapeutic intervention in the second group includes PRP injection once every three weeks and for four sessions. It should be noted that PRP is used autologously and from the patient's own blood product, and the obtained PRP is used only for the patient himself. In this way, 20 ml of the person's venous blood is introduced by a trained nurse in a tube containing sodium citrate and centrifuged for five minutes at a speed of 1500 rpm. Using a sterile syringe, the plasma is transferred to a tube without anticoagulants by a trained nurse and placed in a second centrifuge at 2500 rpm for 20 minutes.The resulting PRP is then collected. Each time PRP is injected intradermally at a dose of 0.1-0.2 ml per injection at a distance of about one centimeter in the interfollicular areas of the frontal and vertebral region by a dermatologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of hair loss. Timepoint: The beginning of the study , 21 , 42 , 63. Method of measurement: Hair pull test.</prim_outcome>
      <prim_outcome>The level of satisfaction of the state of hair loss, increased hair growth and hair quality. Timepoint: The beginning of the study , 21 , 42 , 63. Method of measurement: The satisfaction questionnaire is based on the examination of hair loss before and after the intervention, as well as the satisfaction level regarding the state of hair loss, increased hair growth and hair quality based on a five-point scale from very dissatisfied, which means a score of 0, to very satisfied, which means a score of 5. .</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>Bam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-20</approval_date>
        <contact_name>ethics committee of Bam university of medical sciences</contact_name>
        <contact_address>No.27, Alley 3, Saiyid ush shohada Blvd Bam Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
