<?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>IRCT20090811002330N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effects of plant composition on blood glucose in type 2 diabetic patients "</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effects of a Herbal Mixture of tribulus terrestris, Silybum marianum  ،Trigonella foenum-graecum and cinnamon zeylanicum on Blood Glucose in Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28615</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: En Given that the herbal drug and the drug are placed in the same full capsule, it is natural that the patient and the assessing physician are not aware of the type of medication they receive. Randomization is done based on the round-robin software and each patient will be treated or controlled in the group, Blinding description: A third person encodes as experts, patients, and medications so that the participant remains blind to the allocation of clinical and clinical care groups to the patient and drug compounds.</study_design>
      <phase>2</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients are asked to mix and take a tablespoon of herbal combination on a daily basis, twice before (before lunch and before dinner) with a glass of water and dough. During the study, patients are asked to continue to have a regular diet for diabetics. Intervention 2: Control group:  Control group do not receive herbal medicine.</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:
Data and results will be published in the form of a paper after identification of the participants in the trial

When:
After completing the sampling and analysis of the data and six months after the publication of the article

To whom:
After the publication of this article, access to data is open to students and researchers

Conditions:
In order to produce a cheap and effective drug that can reduce the side effects of treatment in addition to improving blood glucose control by chemical agents. Data will be available if the mixture causes a decrease in blood glucose levels in diabetic patients.

Where to obtain:
Dr. Seyed Hadi Mousavi.Vakilabad Street. Mashhad Medical School. The first floor of the Pharmacology Department

How to obtain:
Request is sent by e-mail. Or receive a data file by visiting Mashhad Medical School and during the administrative process of the Mashhad Medical Sciences Faculty

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Seyed Hadi Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3882 9267</telephone>
        <email>MousaviH@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Seyed Hadi Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3882 9267</telephone>
        <email>MousaviH@MUMS.AC.IR</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female type 2 diabetes</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are at high risk for not controlling glucose with a fixed dose of drug are excluded from this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocrine, nutritional and metabolic diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients are asked to mix and take a tablespoon of herbal combination on a daily basis, twice before (before lunch and before dinner) with a glass of water and dough. During the study, patients are asked to continue to have a regular diet for diabetics.</i_keyword>
      <i_keyword>Control group:  Control group do not receive herbal medicine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TG. Timepoint: Beginning of study. A week after taking the medication. End of the first month of experiment. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>VLDL. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>Blood glucose two hours after food. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>Glycosylated hemoglobin. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>ALT. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>AST. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>Blood creatinine. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</prim_outcome>
      <prim_outcome>BUN. Timepoint: Beginning of study. A week after taking the medication. End of the first. Method of measurement: Measurement of blood parameters using common kits in the market and Autoanalyser.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-14</approval_date>
        <contact_name>Committee on Ethics in Biomedical Research of the University of Medical Sciencesپزشکی</contact_name>
        <contact_address>Daneshgah Street- opposite Daneshgah 18- Quraishi Building Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
