<?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>IRCT20180709040404N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-08</date_registration>
      <primary_sponsor>Shahrood University of Technology</primary_sponsor>
      <public_title>The impact of fennel and Aquatic supplement on menopausal symptoms and diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Fennel Supplements and Water Exercises on Esterogen Levels and some Metabolic Parameters in Diabetic Menopausal Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33570</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants and researchers and data analyst have been blinded to drugs and drugs.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: water treatment group and fennel supplementation. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed. Intervention 2: Second intervention group: Group exercise in water and placebo. Intervention 3: Third intervention group: Fennel supplement group. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed. Intervention 4: Control group: Group of placebo or comparison group.</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:
Effectiveness of fennel supplements and water exercises on menopausal symptoms and diabetes mellitus in diabetic menopause

When:
8 months after the intervention

To whom:
Researchers working in academic and academic institutions

Conditions:
Academic research

Where to obtain:
Sharbanoo Rabiei

How to obtain:
Contact by email:
sh.rabiei1357@gmail.com
Review and answer up to a week

Comments:
does not have</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dِr Ali Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614513654</zip>
        <telephone>+98 232233208</telephone>
        <email>sh.rabiei@shahroodut.ac.ir</email>
        <affiliation>Shahroud University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>sh.rabiei@shahroodut.ac.ir</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes who are postmenopausal women with menopausal symptoms</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: water treatment group and fennel supplementation. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed.</i_keyword>
      <i_keyword>Second intervention group: Group exercise in water and placebo.</i_keyword>
      <i_keyword>Third intervention group: Fennel supplement group. Consumption: Soft FENNELIN capsule containing 100 mg effective ingredient in fennel and placebo, manufactured by «Barij Essence» , as capsules of the same name as R and H twice daily, plus breakfast and dinner. Will be consumed.</i_keyword>
      <i_keyword>Control group: Group of placebo or comparison group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Estrogen levels in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel. Timepoint: To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise. Method of measurement: A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured. To determine estrogen levels, the radioimmune method (RIA) and the human estradiol kit will be used.</prim_outcome>
      <prim_outcome>Insulin serum levels in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel. Timepoint: To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise. Method of measurement: A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured. To measure insulin from methods A laboratory routine will be used.</prim_outcome>
      <prim_outcome>The level of serum glucose in postmenopausal women with type 2 diabetes after 8 weeks of exercise in water and supplementation with fennel. Timepoint: To measure the research variables, blood sampling is performed one day before the beginning of the training period, with 12 hours of fasting and 48 hours after the last session of the exercise. Method of measurement: A blood sample of 5 centimeters of anti-cubital vein per person will be sitting in rest and resting. After 8 weeks of training in water, with fennel supplementation, the amount of estrogen, insulin and glucose will be measured.To measure glucose from methods A laboratory routine will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid Profile (Includes Cholesterol, Triglyceride, HDL.LDL), Type 2 Methicillic-Type Postmenopausal Women. Study of Menopausal Symptoms of Type 2 Diabetic Women. Timepoint: To determine the level of lipid profile, blood transfusion is performed one day before the beginning of the exercise, with 12 hours of fasting and 48 hours after the last training session. Filling in the questionnaire for physical symptoms of menopause includes 11 questions (MRS) one day before the beginning of the exercise and 48 hours after the last training session. Method of measurement: In order to determine the lipid profile, blood sampling at 8:10 am to 5 centimeters of anticyclical vein from each patient will be performed in sitting position. A laboratory routine test will be used to measure serum lipid concentrations. For examination of the physical symptoms Menopause The MRS questionnaire will include 11 questions.</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>Shahrood University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-23</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahrood University of Technology, University Boulevard, Shahrood shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
