<?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>IRCT20151227025726N34</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-09</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of saffron on fatigue symptoms in patients with chronic obstructive pulmonary disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effects of Crocus Sativus herbal product on Chronic Fatigue Syndrome in Patients with Chronic Obstructive Pulmonary Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69608</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. Thirty five block including 2 patients generated with the help of the online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, one patient is assigned to the crocus sativus group and one patient to the control group, Blinding description: Patients included to the study are randomized to two groups of drug and control (crocus sativus and placebo) by a randomizer according to the randomization list taken from www.sealedenvelope.com. The  researcher and data analyst only receive the data in code and were not aware of patients' assignments to the two groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group received capsules containing 30 mg of dry saffron extract (Duralife® prepared by Faran Shimi Company) twice a day for two months. Intervention 2: Control group: Patients in the control group received placebo capsules prepared by Faran Shimi Company twice a day for two months.</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:
All potential data can be shared after blinding.

When:
Six months after publishing the results

To whom:
Researchers working in academic institutions

Conditions:
For research purposes and meta-analysis studies

Where to obtain:
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran

How to obtain:
Official letter to the researchers through Email (fzh.dastan@gmail.com)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Mahmoodian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19569-44413</zip>
        <telephone>+98 21 2712 2227</telephone>
        <email>mahmoodian.reza@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Dastan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1991953381</zip>
        <telephone>+98 21 2712 2227</telephone>
        <email>f_dastan@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 18 years old with chronic obstructive pulmonary disease and chronic fatigue syndrome at the same time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and breastfeeding
suffering from Rheumatoid diseases and osteoarthritis
Having electrolyte disorders
Suffering from adrenal insufficiency
Suffering from obstructive sleep apnea disease
Suffering from other lung diseases such as asthma, lung fibrosis
Patient with acute exacerbation of chronic obstructive pulmonary disease in the last month
History of central nervous system disease (stroke, epilepsy, tumor, history of neurosurgery)
Taking any sleep-sedative drugs, stimulant drugs, antidepressant and anticoagulant drugs
Allergy to saffron or formulation components
Having any known Nervous and mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic obstructive pulmonary 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: Patients in the intervention group received capsules containing 30 mg of dry saffron extract (Duralife® prepared by Faran Shimi Company) twice a day for two months.</i_keyword>
      <i_keyword>Control group: Patients in the control group received placebo capsules prepared by Faran Shimi Company twice a day for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Investigating the effect of herbal product containing crocus sativus on chronic fatigue syndrome in patients with COPD. Timepoint: The beginning of the study, the end of the first month and the end of the second month. Method of measurement: Manchester COPD Fatigue Scale (MCFS) and  Chronic Respiratory Questionnaire (CRQ) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Investigating the effect of crocus sativus herbal product on the quality of life of patients with chronic obstructive pulmonary disease. Timepoint: The beginning of the study, the end of the first and second month. Method of measurement: St. George's Respiratory Questionnaire (SGRQ) questionnaire.</sec_outcome>
      <sec_outcome>Investigating the effect of crocus sativus herbal product on the severity of shortness of breath in patients with COPD. Timepoint: The beginning of the study, the end of the first and second month. Method of measurement: Modified Medical Research Council (mMRC) and Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE Index) score.</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 Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-23</approval_date>
        <contact_name>Ethics Committee in Research of Pharmacy, Nursing and Midwifery Faculties Shahid Beheshti University</contact_name>
        <contact_address>No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
