<?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>IRCT20180712040446N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Mocozift syrup on the success of arteriovenous fistulas</public_title>
      <acronym>AVF=Arteriovenous Fistulas           ESRD= End  Stage Renal Disease</acronym>
      <scientific_title>Evaluation of the effect of Mocozift oral syrup (based on Trachyspermum ammi L) on reducing the failure of arteriovenous fistulas in the first 4 weeks after surgery in End Stage Renal Disease patients (ESRD).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Balance Block Randomization. In this method, random division is done in the form of "blocks" with a predetermined size. For example, if the size of block is 6, the random division operation takes place until the third person is randomly placed in one group, after which the individuals are automatically assigned to another group until the block of 6 is completed. The advantages of this method include the following: It is easy to implement and balance in the number of groups is guaranteed, Blinding description: In this study, both participants, researchers, and data analyzers are blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Increased success of arteriovenous fistulas of the wrist.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The duration of treatment and follow-up for each patient will be a period of 6 weeks. From 2 weeks before the fistula implantation procedure and up to 2 weeks after surgery, the intervention group is given 15 CC of Mocozift oral syrup daily, 15 minutes after each meal in three divided doses. Mocozift oral syrup will be prepared without any label and drug information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed. Mocozift oral syrup is licensed by the Ministry of Health and the Food and Drug Administration. Intervention 2: Control group: The control group will be given 15 CC placebo syrup 15 minutes after each meal in three divided doses. Placebo syrup will be prepared without any pharmaceutical label and information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed.</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>Mohmmad Kamalinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Pharmacy. Niayesh Highway, Valiasr Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1991953381</zip>
        <telephone>+98 21 8820 0118</telephone>
        <email>mkamalinejad@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Morteza Khavaninzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hasheminejd Kidney Center, Vali-nejad Str., Vanak Sq. Vali-e-asr Boul, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1969714713</zip>
        <telephone>+98 21 81161</telephone>
        <email>mkhavanin@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ESRD patients who have been diagnosed by a nephrologist as candidates for implantation of an arteriovenous fistula on the wrist (Cimino fistula).
Patients whom Cimino fistula is performed for the first time.
Patients who blood pressure range is more than 60/100 mm / Hg or less than 145/90 mm/Hg on the day of surgery.
Patients older than 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Blood pressure below 100/60 mm/Hg
Absence of a suitable vessel (helical vein or arterial atherosclerosis) or artery diameter less than 2 and vein diameter less than 2.5 mm
Patients who have used anticoagulants.
Their vascular system is prepared for Cimino fistula VA and is not suitable for radio cephalic VA.
Paralysis or ulceration of the organ where the fistula is to be implanted.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18. 6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End Stage Renal Dieases</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: The duration of treatment and follow-up for each patient will be a period of 6 weeks. From 2 weeks before the fistula implantation procedure and up to 2 weeks after surgery, the intervention group is given 15 CC of Mocozift oral syrup daily, 15 minutes after each meal in three divided doses. Mocozift oral syrup will be prepared without any label and drug information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed. Mocozift oral syrup is licensed by the Ministry of Health and the Food and Drug Administration.</i_keyword>
      <i_keyword>Control group: The control group will be given 15 CC placebo syrup 15 minutes after each meal in three divided doses. Placebo syrup will be prepared without any pharmaceutical label and information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of premature failure of arteriovenous fistulas of the wrist. Timepoint: 6 weeks after surgery. Method of measurement: Observation and examination.</prim_outcome>
      <prim_outcome>Accelerate the maturation of arteriovenous fistulas. Timepoint: 2 weeks before and 2 weeks after surgery. Method of measurement: Observation and examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Erythrocyte Sedimentation Rate. Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Blood Urea Nitrogen (BUN ). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>C Reactive Protein (CRP). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Creatinine (Cr). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>White Blood Cell Count (WBC). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Blood Hemoglobin. Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Red Blood Cell Distribution Width (RDW). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Prothrombin Time (PT). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Partial Thromboplastin Time (PTT). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>International Normalized Ratio (INR). Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</sec_outcome>
      <sec_outcome>Ferritin. Timepoint: Before and after the intervention (weeks 0 and 6). Method of measurement: Blood  Test.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-09</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
