<?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>IRCT20230625058582N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ginger (Zinger offiicinale Roscoe) on patients with slow coronary flow</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Ginger (Zinger offiicinale Roscoe) on clinical symptoms in patients with slow coronary flow on angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70995</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Blinding is done using sealed envelopes. Furthermore, due to using a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.</study_design>
      <phase>2</phase>
      <hc_freetext>Coronary slow flow syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with edible ginger rhizome powder at a dose of 250 mg once daily for one month. Intervention 2: Control group: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo capsule with similar shape, size, and color once daily for one month. The placebo capsule contains 250 mg of Avicel® and is prepared by Dr. Askari's research laboratory at Mashhad University of Medical Sciences.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sara Afshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza hospital, Ebnsina Blvd</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٣٧٩١٣٣١۶</zip>
        <telephone>+98 51 3854 3031</telephone>
        <email>afshars@mum.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sara Afshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza hospital, Ebnsina Blvd</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٣٧٩١٣٣١۶</zip>
        <telephone>+98 51 3854 3031</telephone>
        <email>afshars@mum.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to admission to the study
Age more than 30 years old
Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Stomach ulcers or duodenal ulcers
Taking anticoagulants such as warfarin, aspirin and enoxaparin
Breastfeeding or pregnancy
Consumption of omega 3 (fish oil), ciprofloxacin, loratadine, citalopram, montelukast, and levothyroxine
Kidney stone
History of known congenital heart disease
History of any cardiovascular diseases other than mild coronary atherosclerosis</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: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with edible ginger rhizome powder at a dose of 250 mg once daily for one month</i_keyword>
      <i_keyword>Control group: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo capsule with similar shape, size, and color once daily for one month. The placebo capsule contains 250 mg of Avicel® and is prepared by Dr. Askari's research laboratory at Mashhad University of Medical Sciences.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in the score of quality of life according to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life). Timepoint: Before intervention and one month after beginning the intervention. Method of measurement: According to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequent pain during the day. Timepoint: Before intervention and one months after beginning the intervention. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Duration of pain in minutes. Timepoint: Before intervention and one months after beginning the intervention. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Quality of life according to Seattle Angina Questionare. Timepoint: Before intervention and one months after beginning the intervention. Method of measurement: Seattle Angina Questionare.</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>2023-05-01</approval_date>
        <contact_name>Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad </contact_name>
        <contact_address>Imam Reza Hospital educational complex building, Imam Reza Hospital, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
