<?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>IRCT20130921014727N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-23</date_registration>
      <primary_sponsor>Faculty of Pharmacy, Shahid Behesti University of Medical Sciences</primary_sponsor>
      <public_title>The Evaluation of Safety and Efficacy of Cyproheptadine in Pulmonary Arterial Hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The Pilot Study of Efficacy and Safety of Cyproheptadine in Pulmonary Arterial Hypertension Patients in Massih Daneshvari Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14274</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this study we will use unrestricted or simple randomization. the study utilizes individual sampling. 
we are using a random number table to randomize patients. patients in our center are numbered and even numbers are allocated to the drug group and odd numbers are allocated to the placebo group. numbers on the table select from the top left corner and the direction is toward the bottom right corner. every patient will receive a can containing pills. each pill can is labeled with a specific number that indicates drug or placebo. the numbers' information will have been hidden from patients and researchers by the time of analysis, Blinding description: Each drug label has a number which indicates that the patient using the drug or the placebo. list of numbers are keeping hidden from patients and research team.</study_design>
      <phase>4</phase>
      <hc_freetext>primary pulmonary hypertension.</hc_freetext>
      <i_freetext>Intervention 1: for intervention group: cyproheptadine 4mg PO q12hr for 3 monthes. Intervention 2: for control group: identical placebo tablet q12hr PO for 3 monthes.</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 we need to discuss and decide about reporting IPD</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahab Moradi Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niayesh-Valiasr Crossing, Faculty of Pharmacy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835113</zip>
        <telephone>+98 21 6657 3278</telephone>
        <email>sh.moradi91@outlook.com</email>
        <affiliation>Faculty of Pharmacy, Shahid Behesti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fanak Fahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niayesh-Valiasr Crossing, Faculty of Pharmacy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835113</zip>
        <telephone>+98 21 8805 0939</telephone>
        <email>fahimi@sbmu.ir.ac</email>
        <affiliation>Shahid Behesti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with mean pulmonary arterial pressure (mPAP) ≥25 mmHg (confirmed by catheterization at diagnosis time) and symptomatic pulmonary arterial hypertension (PAH) diagnosis
functional class (FC) II or III according to the world health organization classification
ages between 18 and 75 years old
6-minute walk test (6-MWT) distance of 50 to 450 m
patients receiving stable treatments for PAH, the phosphodiesterase-5 inhibitors or the endothelin-receptor antagonist (bosentan) or both at a dose, and were being stable clinical and hemodynamical status for at least 3 months before randomization
use of anticoagulants, calcium channel blocker and diuretics will be allowed when the medicine or dosage was unchanged for at least last 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>SSRIs, CCBs, MAOIs, sedatives, hypnotics, and alcohol consumers
patients who sleepiness and drowsiness are associated with hazards in their jobs
pregnancy and lactation
symptomatic prostate hypertrophy
BMI≥30
CKD ( SCr.2.5, proteinuria&gt;500mg/d)
COPD
angle-closure glaucoma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I27.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary pulmonary hypertension</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>for intervention group: cyproheptadine 4mg PO q12hr for 3 monthes</i_keyword>
      <i_keyword>for control group: identical placebo tablet q12hr PO for 3 monthes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>WHO functional class. Timepoint: At the beginning and 3 months after intervention. Method of measurement: WHO protocol to determine FC.</prim_outcome>
      <prim_outcome>6-Minute walk test. Timepoint: At the beginning and 3 months after intervention. Method of measurement: the distance which is walked via test by patient.</prim_outcome>
      <prim_outcome>Mean PAP. Timepoint: At the beginning and 3 months after intervention. Method of measurement: measuring by transthoracic echocardiography.</prim_outcome>
      <prim_outcome>Blood level of NT-proBNP. Timepoint: At the beginning and 3 months after intervention. Method of measurement: by blood sample.</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>Faculty of Pharmacy, Shahid Behesti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-18</approval_date>
        <contact_name>Faculty of pharmacy, Shahid Behesti University of Medical Sciences</contact_name>
        <contact_address>Niayesh-Valiasr crossing, Faculty of pharmacy tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
