<?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>IRCT20220614055167N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>The Joint Effects of Dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac for controlling blood glucose of patients with type II diabetes mellitus: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66201</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization, patients will be assigned to intervention groups or placebo groups. The randomization sequence will be determined by one of the individuals who did not participate in the current research. It is necessary to explain that the aforementioned randomization method reduces the possibility of predicting and manipulating the randomization process by people to zero and will lead to the balance of the size of the groups during and at the end of the study, Blinding description: The patients will receive the boxes sealed with 10-digit codes and will receive the original drug or placebo, and they will not be aware of the type of received material. The researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients until the end of the study.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Diabetes mellitus type 2.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac. Intervention 2: Control group: Placebo capsules containing maltodextrin.</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 additional information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Safiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33355948</zip>
        <telephone>+98 41 3334 7882</telephone>
        <email>saeidsafiri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Safiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155668474</zip>
        <telephone>+98 41 3332 7195</telephone>
        <email>saeidsafiri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one year of diagnosis of type 2 diabetes according to the criteria of the World Health Organization
Hemoglobin A1c (HbA1c) &gt; 7.0% or fasting blood glucose &gt; 7.0 mmol/L,
Body mass index (BMI) more than 23 kg/m2 and less than 35.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases
Pregnancy
Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months
A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles, and sumac
Lactating women
Regularly consuming cigarettes or alcohol
Using psychiatric drugs or insulin
Changing the medication regimen during the trial period. For example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</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: Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac</i_keyword>
      <i_keyword>Control group: Placebo capsules containing maltodextrin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Glucometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Human Insulin ELISA Test Kit.</sec_outcome>
      <sec_outcome>Hemoglobin A1c level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: HbA1c Reagent Kit.</sec_outcome>
      <sec_outcome>High density lipoprotein (HDL) levels. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Low density lipoprotein (LDL) levels. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Triglyceride level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Total cholesterol levels. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Aspartate transaminase level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Alanine aminotransferase level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Blood urea nitrogen level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Creatinine level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Prothrombin time. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Bilirubin level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Ferritin level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>Cholinesterase level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</sec_outcome>
      <sec_outcome>High-sensitivity C-reactive protein level. Timepoint: Day 0, 15, 90, 180 post intervention. Method of measurement: Laboratory kits.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-05</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name></contact_name>
        <contact_address>   </contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
