<?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>IRCT20120520009801N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-30</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of rose hip on coronary slow flow</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rose hip alcoholic extract on transthoracic Doppler echocardiography parameters in patients with coronary slow flow</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64960</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used to generate a random allocation sequence with a guarantee of equal allocation of individuals to the two groups is a permutation block created using the website www.randomization.com. With the explanation that each block has 4 members and the shape of the blocks is as follows:
[AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB]
Code A belongs to the intervention group and code B belongs to the control group. Therefore, 18 quadruple blocks were randomly generated by the site and patients were assigned to two study groups based on the sequence obtained from the above blocks, Blinding description: The allocation concealment method is using opaque sealed envelopes with random sequences obtained from the random allocation step. The codes are given to the researcher present in the hospital. This researcher is fully aware of the type of codes. Medications are also given to him on the basis of the number (A or B) and he is fully aware of which drug or placebo. At the end of study, the evaluator (physician) who does not know which drug the patient has received and is aware only of the assigned code, performs the relevant evaluations and after registration, the results are given to the person who performs data analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary artery slow flow syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: tablets containing 250 mg of hydroalcoholic extract of rose hip prepared in the pharmacognosy and pharmaceutical laboratory of Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months. Intervention 2: Control group: Placebo tablets prepared in the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months.</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:
All data is potentially shareable after unidentifiable individuals

When:
starting 6 months after publication

To whom:
People working in academic institutions

Conditions:
Mention the source

Where to obtain:
Amir Hoshang Mohammadpour Phone number: 0098 9153162909 
Email: MohamadpoorAH@mums.ac.ir

How to obtain:
Reply to email within a maximum of one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Hooshang Mohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6519472972</zip>
        <telephone>+98 51 1882 3255</telephone>
        <email>mohamadpoorah@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Hooshang Mohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6519472972</zip>
        <telephone>+98 51 1882 3255</telephone>
        <email>mohamadpoorah@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of slow flow review based on angiography results
CTFC (corrected TIMI frame count) &gt; 27
Obtaining the consent of the patient or the patient's companion</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Aneurysm in the coronary arteries
Patients with hyperhomocysteinemia
Patients with myocarditis
Patients with pericarditis
Patients with cardiomyopathy
The presence of ectasia in epicardial coronary vessels
Not having a suitable view for electrocardiography
Pregnancy or lactation
Kidney or liver failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other forms of angina pectoris</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: tablets containing 250 mg of hydroalcoholic extract of rose hip prepared in the pharmacognosy and pharmaceutical laboratory of Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months</i_keyword>
      <i_keyword>Control group: Placebo tablets prepared in the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PDV (peak diastolic velocity). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>MDV (mean diastolic velocity). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>PDP (peak diastolic pressure). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>MDP (mean diastolic pressure). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Dvti(diastolic time velocity). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Dint (diastolic flow interval). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>VTI (time velocity integral). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>LVEF (left ventricular ejection fraction). Timepoint: at baseline and two months after intervention. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adverse reactions of rose hip tablet. Timepoint: Two months after intervention. Method of measurement: 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-11</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
