<?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>IRCT20181205041856N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-09</date_registration>
      <primary_sponsor>semnan university</primary_sponsor>
      <public_title>The effect of resistance training and ginger supplementation on the index of superoxide dismutase, malondialdehyde and body composition of type 2 diabetes mellitus.</public_title>
      <acronym>دیابت نوع دو</acronym>
      <scientific_title>Study of the effect of eight week resistance training with ginger supplementation on oxidative stress and antioxidant index in type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35760</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Other design features: Resistance training will be performed in a stationary and circular manner. The movements include leg press, chest press, pull-down triceps, knee extention, row seated, forward arm. It has biceps curl and abdominal crunch, Randomization description: First, each of the subjects was coded by one person who was not involved in the research (classmates). Then, from someone who did not know the codes, they were asked to randomly list numbers from 1 to 44. The first 11 first placebo groups, 11 in the supplementation group, 11 in the supplementation and exercise groupe. The last 11 people were placed in the exercise with placebo group, Blinding description: All participants in the study (subjects) were aware of the need to consider the use of ginger supplements in this study, but were not aware of the contents of the capsules (placebo or ginger) that they consumed.
The main investigators (student, supervisor, and counselor) have not been aware of which capsule (placebo or ginger) have been consumed before the end of the research.
The laboratory personnel who have been responsible for sampling and measuring variables have not been informed about which subject the capsule (placebo or ginger) has consumed.</study_design>
      <phase>1</phase>
      <hc_freetext>Type 2 diabetic patients.</hc_freetext>
      <i_freetext>Intervention 1: Control group: placebo Group. Intervention 2: Intervention group: Resistance training group with placebo. Intervention 3: Intervention group: Resistance training with ginger. Intervention 4: Intervention group: Ginger  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:
The protocol was performed for two weeks in both pretest and post-test. You can access the data from Semnan University; Faculty of Humanities; Assistant Professor Seyyed Mohsen Adandi

When:
2015 and 2020

To whom:
seyed mohsen avandi     and hamzeh mohammadi

Conditions:
To help educate the community and students who want to continue the protocol

Where to obtain:
University of Semnan - Faculty of Humanities - Department of Sport Physiology - Dr. Seyyed Mohsen Avadi

How to obtain:
If requested, ask for one week to two weeks by email: hamzeh.gh88@yahoo.com

Comments:
If you have not received an email, please call 09135603693.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyed mohsen avandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan - Opposite Sokan Park - Campus No. 1 - Faculty of Humanities</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19111-35131</zip>
        <telephone>+98 23 3365 4100</telephone>
        <email>president@semnan.ac.ir</email>
        <affiliation>semnan university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed mohsen avandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan - Opposite Sokan Park - Campus No. 1 - Faculty of Humanities</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19111-35131</zip>
        <telephone>+98 23 3365 4100</telephone>
        <email>president@semnan.ac.ir</email>
        <affiliation>semnan university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People between the ages of 40 and 60 year
t least 3 years have passed
Male gender
Member of Diabetes Association of Shiraz
Diagnosis of Type 2 diabetes by a specialist
Informed consent
It has a body composition of 25-29.9 kg / m 2</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Not a professional athlete
Not taking antioxidant supplements, selenium, zinc, beta-carotene, omega-3 ... At least 3 months before the start of the study.
Not participating in another research project
Absence of respiratory, metabolic, cardiovascular diseases
Do not change the oral drug lowering blood glucose
No Diabetic Complications
No smoking and alcohol
Disease associated with softness and bone</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>Placebo</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: placebo Group</i_keyword>
      <i_keyword>Intervention group: Resistance training group with placebo</i_keyword>
      <i_keyword>Intervention group: Resistance training with ginger</i_keyword>
      <i_keyword>Intervention group: Ginger  Group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Two months (from May 15, 2016 to July 15, 2016). Method of measurement: The concentrations Malondialdehyde by spectrophotometer method.</prim_outcome>
      <prim_outcome>Superoxidedismutase. Timepoint: month two  (from May 15, 2016 to July 15, 2016). Method of measurement: Serum supraxid dismutase was calculated by ELISA reader.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: month two (Two months (from May 15 to July 15, 2016)). Method of measurement: body composition using a caliper device was calculated.</sec_outcome>
      <sec_outcome>SOD. Timepoint: Two months from May 15, 2016 to July 15, 2016. Method of measurement: The concentration of superoxide dismutase index was calculated by ELISA method.</sec_outcome>
      <sec_outcome>MDA. Timepoint: Two months from May 15, 2016 to July 15, 2016. Method of measurement: Concentration of MDA by spectrophotometer and Thiobarbituric Acid Test.</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>semnan university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-25</approval_date>
        <contact_name>The Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz, Zand Avenue, opposite the Palestine Street, Central Building of Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
