<?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>IRCT20220107053655N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>The University of Birjand</primary_sponsor>
      <public_title>Effect of Pilates with dill supplement on obesity</public_title>
      <acronym></acronym>
      <scientific_title>Effect of six weeks of Pilates training and dill supplementation on serum levels of Nesfatin-1, insulin resistance with an overweight and obese woman</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61163</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants in this study were Simple Random Sampling by throwing the dice, Blinding description: Participants, data collectors, outcome assessors are blinded in this study, after informing all participants about their grouping and study objectives and they will give informed consent, they will be randomly categorized into each group. For placebo groups, capsules of the same size and the same weight as the dill capsules will be prepared. The data collectors included a laboratory expert, a blood sampler who did not know the procedure of grouping. And all participants will be treated equally on the sampling day. The statistical expert will be unaware of the participant's identities and the file containing the data and groups will be given to him/her.</study_design>
      <phase>3</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pilates+Dill supplement. Do Pilates 3 times a week. 45 minutes per session. Take one dill (1.1g) tablet daily after each meal (breakfast, lunch, dinner). Intervention 2: Intervention group: : Pilates+placebo. Do Pilates 3 times a week. 45 minutes per session. Take one placebo tablet daily after each meal (breakfast, lunch, dinner). Intervention 3: Control group: : dill supplement. Take one tablet (1.1 g) daily after each meal (breakfast, lunch, dinner). Intervention 4: Control group:placebo.Take one placebo tablet daily after each meal (breakfast, lunch, dinner).</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:
Part of the data such as information about the primary outcome

When:
Start of access period 6 months after printing results

To whom:
It will be available to researchers working in academic and scientific institutions

Conditions:
All researchers working in in academic and scientific institutions

Where to obtain:
fatima.sabzevari@gmail.com

How to obtain:
After reading their request as soon as possible if the researcher find out the request valid

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Sajjad 23. Sajjad sstreet</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9718993444</zip>
        <telephone>+98 56 3241 0949</telephone>
        <email>faima.sabzevari@gmai.com</email>
        <affiliation>The University of Birjand</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, Sajjad 23. Sajjad street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9718993444</zip>
        <telephone>+98 56 3241 0949</telephone>
        <email>fatima.sabzevari@gmail.com</email>
        <affiliation>The University of Birjand</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight and obese women (BMI more than 25 kg per square meter) with an age range of 25 to 45 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Overweight and obese women (BMI more than 25 kg per square meter) with an age range of 25 to 45 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pilates+Dill supplement. Do Pilates 3 times a week. 45 minutes per session. Take one dill (1.1g) tablet daily after each meal (breakfast, lunch, dinner)</i_keyword>
      <i_keyword>Intervention group: : Pilates+placebo. Do Pilates 3 times a week. 45 minutes per session. Take one placebo tablet daily after each meal (breakfast, lunch, dinner)</i_keyword>
      <i_keyword>Control group: : dill supplement. Take one tablet (1.1 g) daily after each meal (breakfast, lunch, dinner)</i_keyword>
      <i_keyword>Control group:placebo.Take one placebo tablet daily after each meal (breakfast, lunch, dinner)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nesfatin-1. Timepoint: 12 hours before the start of the intervention and 12 hours after the end of the intervention. Duration of intervention 6 weeks. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin resistance. Timepoint: 12 hours before the start of the intervention and 12 hours after the end of the intervention. Duration of intervention 6 weeks. Method of measurement: Blood 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>The University of Birjand</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-08</approval_date>
        <contact_name>Ethics committee of Birjand University</contact_name>
        <contact_address>Sajjad street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
