<?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>IRCT20230527058308N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-01</date_registration>
      <primary_sponsor>Shahid Chamran University of Ahvaz</primary_sponsor>
      <public_title>"Investigating the effect of spirulina on liver enzymes"                                       "The effect of yoga with weight on liver enzymes"</public_title>
      <acronym></acronym>
      <scientific_title>The effect of yoga exercise with dumbbells along with spirulina supplement on liver enzymes of elderly Bushehr women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70385</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Gradually increasing the time of training sessions in order to increase the training load and not to perform other sports activities at the same time during the study period, Randomization description: After filling out the consent forms and medical records, they were randomly divided into 4 groups based on body mass index and age.</study_design>
      <phase>3</phase>
      <hc_freetext>To identify and prevent liver problems or diseases affecting liver enzymes.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: participating in yoga sessions with weights and received a spirulina supplement. (500g spirulina capsules three times a day before each meal for 8 weeks). Intervention 2: The second intervention group: only participating in yoga sessions with weights without receiving supplements. (Actually, they received Nama supplement or placebo in the form of 500 gram capsules with starch to consume 3 times a day). Intervention 3: The third intervention group: this group only received supplements. (500g spirulina capsules three times a day before each meal for 8 weeks). Intervention 4: Control group: This group also did not participate in any exercise sessions and supplement consumption.</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 a part of the data, such as the information related to the main result or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
The resulting data will be available only to researchers working in academic and scientific institutions

Conditions:
Candidates present in the study and people for further research can access the data, and the data can also be used to participate in congresses or other articles.

Where to obtain:
To the first author or the responsible author

How to obtain:
Each of the parts of the documents that are allowed to be accessed will be reviewed by announcing the request, after clarifying and receiving the necessary documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohadeseh Bandarrigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516794754</zip>
        <telephone>+98 77 3344 7040</telephone>
        <email>m-bandarrigi@stu.scu.ac.ir</email>
        <affiliation>The university of Ahvaz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohadeseh Bandarrigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516794754</zip>
        <telephone>+98 77 3344 7040</telephone>
        <email>m-bandarrigi@stu.scu.ac.ir</email>
        <affiliation>The university of Ahvaz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not suffering from autoimmune diseases
Not suffering from thyroid problems and diabetes
Elderly women over 60 years old
Not having allergies or sensitivities to seafood
Resident of Bushehr city</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>68 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: participating in yoga sessions with weights and received a spirulina supplement. (500g spirulina capsules three times a day before each meal for 8 weeks)</i_keyword>
      <i_keyword>The second intervention group: only participating in yoga sessions with weights without receiving supplements. (Actually, they received Nama supplement or placebo in the form of 500 gram capsules with starch to consume 3 times a day)</i_keyword>
      <i_keyword>The third intervention group: this group only received supplements. (500g spirulina capsules three times a day before each meal for 8 weeks)</i_keyword>
      <i_keyword>Control group: This group also did not participate in any exercise sessions and supplement consumption.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ََAspartate aminotransferase (AST) enzymes. Timepoint: Measurement of blood cholesterol at the beginning of the study (before the start of the intervention) and after the end of the study (60 days). Method of measurement: blood draw.</prim_outcome>
      <prim_outcome>Alanine aminotransferase (ALT). Timepoint: Measurement at the beginning of the study (before the start of the intervention) and after the end of the study (60 days). Method of measurement: blood draw.</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>Shahid Chamran University of Ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-14</approval_date>
        <contact_name>Ethics Committee of Ahvaz Shahid Chamran University</contact_name>
        <contact_address>Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
