<?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>IRCT20191204045612N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Spirulina supplementation on ulcerative colitis patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Spirulina supplement (Arthrospira platensis) on disease activity indices, quality of life, mood, fatigue, serum antioxidant status and serum pentraxin  3 levels in patients with ulcerative colitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44012</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method using random number table is used. This method first uses a random number table, which is a set of numbers that have no pattern or order and which is completely generated. The researcher divides these numbers randomly between the intervention and placebo groups. With the presence of clients, the researcher begins to read the numbers in the specified order. Each client receives its own number and is randomly assigned to either the intervention or the placebo group, Blinding description: This study is a double-blind study. Given that the researcher and patient should not be aware of the contents of the capsules, the third person places the placebo and spirulina into identical and similar capsules and containers and encodes them randomly. Spirulina and placebo are then presented to the researcher with a code to disclose to the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ulcerative colitis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive Spirulina (Arthrospira platensis) 1 g  daily (receive two 500 mg capsules daily) for 8 weeks. Intervention 2: Control group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive starch 1 g daily (receive two 500 mg capsules daily) for 8 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad hassan entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>009836680048</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad hassan entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>009836680048</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild to moderate ulcerative colitis in the age range of 18 to 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with severe ulcerative colitis
Individuals in pregnancy or breastfeeding condition.
Taking antidepressants and anxiety medications.
Taking antioxidant and omega-3 supplements in the last three months.
Smokers or alcohol consumers.
Patients with kidney, liver, thyroid and parathyroid, gastrointestinal and heart disease and cancer disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive Spirulina (Arthrospira platensis) 1 g  daily (receive two 500 mg capsules daily) for 8 weeks.</i_keyword>
      <i_keyword>Control group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive starch 1 g daily (receive two 500 mg capsules daily) for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pentraxin 3. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: Eliza kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: Diagnostic kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: Diagnostic kit.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: Diagnostic kit.</prim_outcome>
      <prim_outcome>Erythrocyte Sedimentation Rate. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: Measurement of erythrocyte sedimentation rate.</prim_outcome>
      <prim_outcome>Disease activity indices. Timepoint: Before intervention and 8 weeks after initiation of Spirulina supplementation. Method of measurement: SCCAI questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Use scales.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Calculation.</sec_outcome>
      <sec_outcome>Waist. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: measurement.</sec_outcome>
      <sec_outcome>Neck circumference. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Measurement.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Measurement.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Measurement.</sec_outcome>
      <sec_outcome>Dietary intake. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: 24-h recall.</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: FSS questionnaire.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: IPAQ questionnaire.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: SIBDQ-9 questionnaire.</sec_outcome>
      <sec_outcome>Sleep Quality. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Sleep duration. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Subjective sleep quality. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Sleep latency. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Sleep efficiency. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Sleep disturbances. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Use of sleep medication. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Day-time dysfunction. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Depression status. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: DASS 21 questionnaire.</sec_outcome>
      <sec_outcome>Stress status. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: DASS 21 questionnaire.</sec_outcome>
      <sec_outcome>Anxiety status. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: DASS 21 questionnaire.</sec_outcome>
      <sec_outcome>Stool frequency. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: SIBDQ-9 questionnaire.</sec_outcome>
      <sec_outcome>Bowel distress and cramp. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: SIBDQ-9 questionnaire.</sec_outcome>
      <sec_outcome>Gas excretion of bowel. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: SIBDQ-9 questionnaire.</sec_outcome>
      <sec_outcome>Flatulence. Timepoint: Before intervention and 8 weeks after initiation of spirulina supplementation. Method of measurement: SIBDQ-9 questionnaire.</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>Isfahan university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-25</approval_date>
        <contact_name>Vice-Chancellor in Research Affairs -Medical University of Isfahan</contact_name>
        <contact_address>Hezar jarib Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
