<?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>IRCT20190618043924N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-22</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of fenugreek seed on the treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of fenugreek seed on anthropometric indicators, some blood factors, depression, and anxiety in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40340</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: binary random block method  
Unit of randomization: individual
Randomization strata: age, sex, body mass index
Tools used in randomization: coin
The allocation was concealed from the clinical recruitment staff until each patient had entered the trial and received a randomization code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-insulin-dependent diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 grams of powdered fenugreek seeds in doses of 5 grams three times a day between meals, dissolved in water, besides routine diabetic drugs, for 8 weeks. Intervention 2: Control group:  routine diabetic drugs for 8 weeks.</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:
Only the data from the original outcomes can be shared

When:
the results will become available after publication

To whom:
some additional supporting information can be shared for anyone in academic institutions who applies

Conditions:
using additional supporting information is just for receiving more details about the study and should not be used anywhere without the permission of the researchers

Where to obtain:
for additional supporting information, you can email Dr. Rahele Tavakoly (tavakkoli.rahele@yahoo.com)

How to obtain:
1. Request letter
2. The reasons for the request and the type of uses of the additional supporting information
3. Applicant'sacademic profile and applicant's organization's name
4. An official contract with a signed and authentic signature from the applicant's organization that the use of the information is under the consent of the researchers.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rahele Tavakoly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh-E-Alavi Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5086</telephone>
        <email>tavakkoli.rahele@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahele Tavakoly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh-E-Alavi Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5086</telephone>
        <email>tavakkoli.rahele@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>type 2 diabetes
30-65 years old
up to 10 year diabetic history
Body Mass Index&lt;35</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>insulin therapy
menopause or hysterectomy (women)
having any certain diseases or using any certain medications other than diabetic ones
having allergy to Fabaceae family herbs
using dietary supplements and other medicinal plants for at least three months prior to the study</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15 grams of powdered fenugreek seeds in doses of 5 grams three times a day between meals, dissolved in water, besides routine diabetic drugs, for 8 weeks</i_keyword>
      <i_keyword>Control group:  routine diabetic drugs for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hip circumference. Timepoint: baseline and 8 weeks after intervention. Method of measurement: measuring tape.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: baseline and 8 weeks after intervention. Method of measurement: measuring tape.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: baseline and 8 weeks after intervention. Method of measurement: sphygmomanometer.</prim_outcome>
      <prim_outcome>Alanine Amino Transferase. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Alkaline phosphatase. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Depression and anxiety. Timepoint: baseline and 8 weeks after intervention. Method of measurement: "Hospital Anxiety and Depression Scale" questionnaire.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Low-density lipoprotein. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>High-density lipoprotein. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Fasting plasma glucose. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>2-h post prandial glucose. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Blood urea nitrogen. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: baseline and 8 weeks after intervention. Method of measurement: blood sampling and commercial kits.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-10</approval_date>
        <contact_name>Ethics Committee of Kerman university of medical sciences</contact_name>
        <contact_address>Haft Bagh-E-Alavi Highway Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
