<?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>IRCT20171211037832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-01</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of traditional medicine COLIT RELIF in patients with ulcerative colitis</public_title>
      <acronym></acronym>
      <scientific_title>THE EFFECT OF IRANIAN TRADITIONAL MEDICINE PRODUCT(COLIT RELIEF) IN PREVENTION THE RELAPSE OF ULCERATIVE COLITIS PAITIENT</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The research is experimental and experimental for 10 weeks for each patient. Patients were randomly assigned to two groups of 19 patients and 21 subjects divided into two groups: TAPERING, prednisolone 10 mg starting with 10 mg Sulfasalazine They also receive 2.5 to 3 grams per day. Our control group, along with its routine, received placebo in a 250 mg capsule once a day, and in the intervention group, traditional medicine COLIT RELIF was added to the patient's drug regimen in the form of a 250 mg capsule once a day, Blinding description: The present study is three-blind. This blindness was done by the patient, the pharmacist, and the person who analyzed the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ulcerative colitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The product of traditional medicine COLIT RELIF is presented in the form of a 250 mg capsule once a day along with food and also prednisolone starting at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day. Intervention 2: Control group: Control group: Placebo in the form of a 250 mg capsule once a day as well as prednisolone started at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day.</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:
The collected data includes a small fraction of the demographic characteristics and the mean clinical stability score. After being blinded, the analyst gets it.

When:
Get started two years after the results are published

To whom:
Researchers in the field of traditional medicine

Conditions:
If comparing the doses of the drug between the intervention and the control, or comparing the quality of the data with the new data.

Where to obtain:
Faculty of Ardakan Traditional Medicine

How to obtain:
In coordination with the Research Council and the Research and Student Vice-Chancellor of the Faculty of Traditional Medicine, Ardakan Branch, and after passing through its legal procedures.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Emtiazy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Imam Khomeini street, Ardakan</address>
        <city>Ardakan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951737915</zip>
        <telephone>+98 35 2723 8917</telephone>
        <email>dr.emtiazy@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Emtiazy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Traditional Medicine University, Imam Khomeini street, Ardakan</address>
        <city>Ardakan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951737915</zip>
        <telephone>+98 35 2723 8917</telephone>
        <email>dr.emtiazy@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>For patients, the diagnosis of infectious colitis is caused by Clostridium deficiency colitis, ischemic colitis, and drug dependent colitis.
Patients with moderate to severe ulcerative colitis were diagnosed in the last month of the REMISSION phase.
Failure to use other complementary and alternative therapies
Completion of consent form in an informed manner</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
The creation of a drug complication or allergy
Dissatisfaction with the continuation of treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A06.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K51.0Ulcerative (chronic) pancolitisbackwash ileitis</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>Intervention group: Intervention group: The product of traditional medicine COLIT RELIF is presented in the form of a 250 mg capsule once a day along with food and also prednisolone starting at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day</i_keyword>
      <i_keyword>Control group: Control group: Placebo in the form of a 250 mg capsule once a day as well as prednisolone started at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day...</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The results of this study could be used to propose a new treatment protocol for ulcerative colitis. Timepoint: Effect of traditional medicine coliT relife before intervention and in weeks 2, 4, 6, 8 and 10 after intervention. Method of measurement: Regular medical check-ups.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Proof of scientific validity and efficacy of traditional Iranian medicine in the treatment of ulcerative colitis. Timepoint: Before intervention and weeks 2, 4, and 6, 8 and 10 after intervention. Method of measurement: Regular patient visit and opinion form.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-26</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Yazd University of Medical Sciences. Shahid Bahonar Square yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
