<?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>IRCT20221215056829N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-20</date_registration>
      <primary_sponsor>Pak Emirates Military Hospital</primary_sponsor>
      <public_title>narrow band UVB for post herpetic neuralgia (PHN)</public_title>
      <acronym></acronym>
      <scientific_title>Effect of narrow band UVB in combination with oral Acyclovir versus oral Acyclovir alone in prevention of Post Herpetic Neuralgia in patients with Herpes Zoster</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbers table into two groups of 50 patients each. Each patient was assigned a number at enrollment which defined a study assignment (Oral Acyclovir alone vs Oral Acyclovir plus nbUVB).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients suffering from Herpes Zoster and presenting within 7 days of onset of rash.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin, plus nbUVB delivered only to the affected dermatome while the rest of body was covered with clothing. The starting dose of nbUVB was 0.21 J/cm2 and it was increased by increment of 10% on every session as long as no adverse effects including persistent erythema, burning or itching were reported by the patient. The sessions were repeated 03 times per week to a maximum of 15 sessions or less if the pain settles completely. Intervention 2: Control group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin. nbUVB was not administered to this group.</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:
Effect of narrow band UVB in prevention of post herpetic neuralgia

When:
starting 1 month after publication

To whom:
people working in academic institutions

Conditions:
data will be allowed to use after taking permission from the author

Where to obtain:
data will be obtainable from author Abrar Ahmad Khalid, abrar2437@gmail.com

How to obtain:
A request to be sent via given email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abrar Ahmad Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abid Majeed Road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 8511241</telephone>
        <email>abrar2437@gmail.com</email>
        <affiliation>Pak Emirates Military Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abrar Ahmad Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abid Majeed Road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 8511241</telephone>
        <email>abrar2437@gmail.com</email>
        <affiliation>Pak Emirates Military Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both genders
Patients having herpes zoster as per operational definition, reporting within 07 days of eruption of vesicles</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients reporting after 07 days of onset of rash
Patients having history of photosensitivity
Patients who are unable to stand due to any musculoskeletal abnormalities
Patients who are claustrophobic
Patients in which genitalia is involved (L1 dermatome), as genitalia is usually shielded during nbUVB irradiation
Patients in which scalp is involved (C2 dermatome), as because of hair scalp will not be properly irradiated</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Zoster [herpes zoster]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin, plus nbUVB delivered only to the affected dermatome while the rest of body was covered with clothing. The starting dose of nbUVB was 0.21 J/cm2 and it was increased by increment of 10% on every session as long as no adverse effects including persistent erythema, burning or itching were reported by the patient. The sessions were repeated 03 times per week to a maximum of 15 sessions or less if the pain settles completely.</i_keyword>
      <i_keyword>Control group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin. nbUVB was not administered to this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post herpetic neuralgia. Timepoint: At completion of treatment and after 3 months. Method of measurement: Verbal Rating Score.</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>Pak Emirates Military Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-02</approval_date>
        <contact_name>Ethical Review Committee and Research Department Pak Emirates Military Hospital</contact_name>
        <contact_address>Abid Majeed Road Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
