<?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>IRCT20200725048200N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-11</date_registration>
      <primary_sponsor>Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficacy of Cranbery in treatment of Fatty Liver</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of Cranbery in management of non-alcoholic Fatty Liver Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49884</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants will receive cranberry extract and placebo as a double-sided blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility. Intervention 2: Control group:  The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.</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:
In this study, patients' identities are not shared.

When:
Access period starts 12 months after the results are published.

To whom:
Data will only be available to researchers in this study.

Conditions:
The data will be available to researchers only for meta-analysis study and for data analysis.

Where to obtain:
Receipt of data will be done through the scientific respondent of the study.

How to obtain:
To receive the data, an email is sent to the scientific respondent and the reason for receiving the data is mentioned in detail and if the reasons are appropriate, the information will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kourosh Masnadi shirazi nezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>kurmas23@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kourosh Masnadi shirazi nezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>kurmas23@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with non-alcoholic fatty liver grade1,  2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction
Rule out the diagnosis of fatty liver
Drug intolerance
Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture
alcohol consumption
antioxidant and vitamins supplements other that vitamin E
pregnant and lactating mothers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</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 first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.</i_keyword>
      <i_keyword>Control group:  The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of lipid profile level before and after cranberry and placebo use. Timepoint: Study time and 6 months after taking cranberry extract and placebo. Method of measurement: Perform blood tests.</prim_outcome>
      <prim_outcome>Determination of serum insulin and fasting glucose levels before and after cranberry and placebo. Timepoint: Study time and 6 months after taking cranberry extract and placebo. Method of measurement: Perform blood tests.</prim_outcome>
      <prim_outcome>Determination of Ultrasound grade  before and after cranberry and placebo. Timepoint: Study time and 6 months after taking cranberry extract and placebo. Method of measurement: Ultrasound device.</prim_outcome>
      <prim_outcome>Determination of serum levels of liver enzymes before and after cranberry and placebo. Timepoint: Study time and 6 months after taking cranberry extract and placebo. Method of measurement: Perform blood tests.</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>Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-20</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
