<?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>IRCT20130418013058N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Crocin and Curcumin Effect on Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Efficacy of Crocin and Curcumin Combinational Capsule on the severity of fatigue, pain and quality of life in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each capsule container will be assigned a four-digit code using a random number table. These codes will be randomly labeled onto each container by the pharmacist. The therapist will randomly provide the containers to patients without knowledge of the medication type. Consequently, the nature of each code will remain unknown until the results are analyzed, Blinding description: Crocin-curcumin capsules and placebo capsules will be prepared with similar shape, color, and size, stored in dark containers, and coded by a pharmacist. The treating physician, researcher, and patient will be blinded to the codes on the aforementioned containers.</study_design>
      <phase>2-3</phase>
      <hc_freetext>MS or Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During the two-month period, they will receive oral capsules containing a combination of 7.5 mg crocin and 150 mg curcumin twice daily (BID), totaling 15 mg crocin and 300 mg curcumin per day. Intervention 2: Control group:  Receiving placebo, with placebo capsules administered twice daily (BID) throughout the two-month period.</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 After the project, the information will be published in the form of an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. seyed Ahmad Mohajeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188617871</zip>
        <telephone>+98 51 3882 3251</telephone>
        <email>mohajeria@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Ahmad Mohajeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188617871</zip>
        <telephone>+98 51 3882 3251</telephone>
        <email>mohajeria@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definite diagnosis of multiple sclerosis confirmed by the neurologist, based on the McDonald criteria, with a minimum of 6 months since diagnosis and a disease duration of no more than 10 years.
Patients with relapsing-remitting multiple sclerosis (RRMS) receiving first-line and second-line disease-modifying therapies.
Absence of relapse one month prior to study enrollment.
Willingness to participate in the study.
Expanded Disability Status Scale (EDSS) score of 0 to 5.
Fatigue Severity Scale (FSS) score equal to or greater than 4.
Presence of chronic pain in at least one limb and a Numerical Rating Scale (NRS) pain intensity score greater than 4.
Patients with multiple sclerosis receiving first-line and second-line disease-modifying therapies (dimethyl fumarate, reciGen, Betaferon, teriflunomide, fingolimod, glatiramer acetate).
Absence of underlying comorbidities such as diabetes, cardiovascular diseases, and genetic disorders.
Patient compliance: ability to participate in interviews and communicate feelings and experiences.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of other underlying comorbidities (chronic diseases, cardiovascular, endocrine, respiratory, hepatic, renal, musculoskeletal disabilities), mental disorders, and severe depression.
Addiction to alcohol, narcotics, and psychotropic substances.
History of saffron or turmeric allergy.
Pregnancy and lactation.
Presence of severe infection and inflammation, varicose veins, active thrombosis, limb injuries such as fractures.
Expanded Disability Status Scale (EDSS) score greater than 6.
New onset of any other serious illness such as cardiac, hepatic, and renal diseases during treatment.
Performance of strenuous daily exercise.
Any use of anti-inflammatory and antioxidant drugs as supplements, or amantadine as an anti-fatigue medication.
Unwillingness to participate in the study or continue the treatment process.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</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: During the two-month period, they will receive oral capsules containing a combination of 7.5 mg crocin and 150 mg curcumin twice daily (BID), totaling 15 mg crocin and 300 mg curcumin per day</i_keyword>
      <i_keyword>Control group:  Receiving placebo, with placebo capsules administered twice daily (BID) throughout the two-month period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before and two months after the intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) fatigue assessment questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before and two months after the intervention. Method of measurement: VAS or visual analog scale questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and two months after the intervention. Method of measurement: Quality of Life Questionnaire Multiple Sclerosis Impact Scale (MSIS-29).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual function. Timepoint: Before and two months after the intervention. Method of measurement: Men (International Index of Erectile Function ) and women's (Female Sexual Function Index ) sexual health 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-22</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
