<?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>IRCT20121216011763N61</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-05</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of saffron supplementation on Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of saffron supplementation on some indices of inflammation and oxidative stress, stage of disease, motor and non-motor symptoms, mental health, cognitive impairment, intestinal permeability, gastrointestinal symptoms, appetite, fatigue, quality of life, and sleep quality in patients with Parkinson's disease: A triple blind randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75378</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done using a four-block randomization  method. For this purpose, people will be classified into 4 states based on the variables of gender and  stage of the disease and people with the same  states will be randomly assigned to intervention and placebo groups in a 1:1 ratio. Block randomization will be done using a list of random numbers generated by the website https://www.sealedenvelope.com/simple and by an independent researcher, Blinding description: This study is a triple blind clinical trial. The saffron supplement and its placebo will be packed identically in terms of (color, shape and smell) in  similar boxes. In order to carry out this research in a triple blind manner,   patients, researchers who are responsible for interview, sampling and evaluating tests and statistical analyzes will be blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For 12 weeks, daily intake of one tablet containing 100 mg of first-class Sargol saffron prepared by Mojtahedi Company   (preparation of  tablets will be done at the Faculty of Pharmacy). Intervention 2: Control group: For 12 weeks, daily intake of one tablet containing 100 mg of lactose powder prepared by Pak Azma Company (preparation of the   tablets will be done at the Faculty of Pharmacy).</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>Dr. Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Research &amp; Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3060</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Research &amp; Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan</address>
        <city>اصفهان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3060</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Agreement for participation in the study
Age of 45  years old or more
Diagnosis of Parkinson's disease based on United Kingdom PD Society Brain Bank (UKPDSBB) criteria
Having the Hoehn and Yahr score less than 5
BMI equal or less than 40</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Adherence to a specific diet or consumption of saffron supplement in the last 3 months
Patients with other neurodegenerative diseases such as Huntington's disease, Wilson's disease
Central nervous system infections such as meningitis
Having a Hoehn and Yahr  score of 5 out of 5
Patients with a history of saffron allergy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For 12 weeks, daily intake of one tablet containing 100 mg of first-class Sargol saffron prepared by Mojtahedi Company   (preparation of  tablets will be done at the Faculty of Pharmacy)</i_keyword>
      <i_keyword>Control group: For 12 weeks, daily intake of one tablet containing 100 mg of lactose powder prepared by Pak Azma Company (preparation of the   tablets will be done at the Faculty of Pharmacy)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stage of disease. Timepoint: At baseline and after 12 weeks. Method of measurement: Hoehn and Yahr scale.</prim_outcome>
      <prim_outcome>Serum level of  C-reactive protein (CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Biorex Fars kit.</prim_outcome>
      <prim_outcome>Symptoms of Parkinson's disease (motor and non-motor). Timepoint: At baseline and after 12 weeks. Method of measurement: Using the MDS-UPDRS questionnaire.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.</prim_outcome>
      <prim_outcome>Activity of Catalase enzyme. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.</prim_outcome>
      <prim_outcome>Malondialdehyde (MDA) serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.</prim_outcome>
      <prim_outcome>Glutathione serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.</prim_outcome>
      <prim_outcome>Zonulin serum level. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: At baseline and after 12 weeks. Method of measurement: Parkinson's Disease Questionnaire - 39.</sec_outcome>
      <sec_outcome>Mental health (Depression, stress, anxiety). Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: At baseline and after 12 weeks. Method of measurement: PDSS questionnaire.</sec_outcome>
      <sec_outcome>Cognitive status. Timepoint: At baseline and after 12 weeks. Method of measurement: AMT questionnaire.</sec_outcome>
      <sec_outcome>Anthropometric indices. Timepoint: At baseline and after 12 weeks. Method of measurement: Seca scale and portable stadiometer.</sec_outcome>
      <sec_outcome>Gastrointestinal symptoms. Timepoint: At baseline and after 12 weeks. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: At baseline and after 12 weeks. Method of measurement: SNAQ Questionnaire.</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: At baseline and after 12 weeks. Method of measurement: PFS-16 Questionnaire.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: At baseline and after 12 weeks. Method of measurement: Digital sphygmomanometer.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-20</approval_date>
        <contact_name>Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
