<?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>IRCT20190103042219N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effects of resistance training and curcumin on fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Effects of resistance training and curcumin supplementation on the liver biochemical markers levels and structure in old women with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43788</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each subject was assigned a code. 
The codes were given to an uninformed person who was also the master of the plan.
The teacher found 45 randomly codes by using the Internet and assigned to each group, Blinding description: Subjects were identified using the code.
Subjects were categorized by a unknown and groups has code.
Only the code was given to the lab and the name of the subject and group was not specified.
Only the code was given to the analysis.
The supplement and placebo subjects were unaware of their group name.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Resistance training: 1-The warm-up consisted of working out with a fixed bike for 8 minutes and 5 minutes of light stretching exercises. 2- The nonlinear resistance training program used in this study has been proposed by Nikseresht et al. (Nikseresht et al., 2014). Each session took about 60-70 minutes for main training (plus about 20 minutes for warm-up and cool-down), three days a week (nonconsecutive) which lasted 12 weeks. Intervention 2: Intervention group: Curcumin supplement: Participants in supplement groups were asked to take one curcumin capsule (Curcumin 80 mg as Nanomicelle produced by Minoo Pharmaceutical Co.) per day after breakfast. Intervention 3: Intervention group:   Resistance training with curcumin supplement. This group has curcumin supplementation plus non-liner resistance exercise training. Intervention 4: Control group: Plasebo. Has no exercise training and take one placebo capsule per day after breakfast for 12 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:
Liver enzyme

When:
4 month

To whom:
Researchers

Conditions:
For article

Where to obtain:
Researcher

How to obtain:
Contact with researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ali Azarbayjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sohanak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955847781</zip>
        <telephone>0214460017</telephone>
        <email>m_azarbayjani@iauctb.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Azarbayjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sohanak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955847781</zip>
        <telephone>+98 21 4460 0070</telephone>
        <email>m_azarbayjani@iauctb.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being obese
Elderly (60-71 years old)
Female
Having fatty liver disease
Untrained</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>71 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Addiction to smoking
Alcohol abuse
Doing regular physical exercises in the last 6 months
Having lung disease
Kidney disease
Cardiovascular disease
Liver transplantation
Estrogen intake
High blood pressure
Chronic disorders
Taking special medications such as statins
Having a special dietary program
Allergy to curcumin
Having a cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Resistance training: 1-The warm-up consisted of working out with a fixed bike for 8 minutes and 5 minutes of light stretching exercises. 2- The nonlinear resistance training program used in this study has been proposed by Nikseresht et al. (Nikseresht et al., 2014). Each session took about 60-70 minutes for main training (plus about 20 minutes for warm-up and cool-down), three days a week (nonconsecutive) which lasted 12 weeks.</i_keyword>
      <i_keyword>Intervention group: Curcumin supplement: Participants in supplement groups were asked to take one curcumin capsule (Curcumin 80 mg as Nanomicelle produced by Minoo Pharmaceutical Co.) per day after breakfast.</i_keyword>
      <i_keyword>Intervention group:   Resistance training with curcumin supplement. This group has curcumin supplementation plus non-liner resistance exercise training.</i_keyword>
      <i_keyword>Control group: Plasebo. Has no exercise training and take one placebo capsule per day after breakfast for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver enzymes, including alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP). Timepoint: Blood samples were taken before the intervention and 48 hours after 8 weeks of training. Method of measurement: ALT, AST, ALP levels were measured by Pars Azmon Kit.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-26</approval_date>
        <contact_name>Islamic Azad University, Kazeroun Branch, Iran with ethical code: IR.IAU.KAU.REC.1398.079</contact_name>
        <contact_address>Islamic Azad university Kazeroun Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
