<?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>IRCT20100124003146N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-01</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of astragalus root extract on  chronic fatigue syndrome in nurses</public_title>
      <acronym></acronym>
      <scientific_title>The effect of astragalus root extract on  chronic fatigue syndrome in nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67038</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be used in this study. First, the randomization list will be prepared using the online randomization software in blocks of 4. The letter A will be chosen for the intervention group and the letter B will be chosen for the placebo group. Sampling is continuous and then the samples with entry conditions will be placed in groups in order and one after the other based on the previously prepared list of the output of www.sealedenvelop.com online randomization software, Blinding description: The present study is triple blind. The participants will not know the type of group they will be assigned to and will only receive the capsule containing the drug or starch. It should be noted that the drug and placebo are poured into gelatin capsules of the same color. In addition, both substances are white, so the participants cannot notice the type of group when they open the capsules. The second blinding is related to the person prescribing the medicine, who will receive the prepared medicines inside the coded plastic envelopes, and after referring the participant to him, the prescription referee and the code of the envelope will be recorded in the participant's sheet. The third blinded person will be a statistical analyst, whose names of the groups will be entered in the SPSS software and will be available to him.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic fatigue syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In this study, the root extract extracted in hydroalcoholic form is prepared by Barij-Essance company in 500 mg capsules and will be given to the intervention group samples for one month to consume one capsule twice a day (morning and night). Intervention 2: Control group: The samples randomly assigned to the control group received capsules containing corn starch (500 mg per capsule provided by Barij-essence) twice a day for one month, which did not differ in appearance from the root extract.</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:
the results related to the main outcome will be distributed.

When:
Access will start from the time the results are printed to forever.

To whom:
Academic and industrial researchers are allowed to submit data requests.

Conditions:
The applicant must clearly state the purpose of the data request to the person in charge of the data, and if approved by the University Research Council, non-identifiable data will be provided to him.

Where to obtain:
Dr. Ismail Azizi Fini, email: azizifinies@yahoo.com

How to obtain:
The data will be sent in less than 24 hours after sending the request via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ismail Azizi-Fini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>azizifinies@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Esmail Azizi-Fini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>azizi-es@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have criteria for chronic fatigue syndrome.
20 to 50 years old.
A nurse working in a hospital.
Willingness to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
Not taking medicine for 4 consecutive days
Lack of access to samples
receiving anticoagulants (warfarin-aspirin-coumadin )
Blood pressure drop (systole less than 100 and diastole less than 60) during study continuously or intermittently during the day</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G93.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postviral fatigue syndrome</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: Intervention group: In this study, the root extract extracted in hydroalcoholic form is prepared by Barij-Essance company in 500 mg capsules and will be given to the intervention group samples for one month to consume one capsule twice a day (morning and night).</i_keyword>
      <i_keyword>Control group: The samples randomly assigned to the control group received capsules containing corn starch (500 mg per capsule provided by Barij-essence) twice a day for one month, which did not differ in appearance from the root extract.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chronic fatigue syndrome. Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention. Method of measurement: DePaul Symptom Questionnaire - Short Form (DSQ-SF).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention. Method of measurement: Beck Anxiety Inventory.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Index.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-13</approval_date>
        <contact_name>Faculty of Nursing and Midwifery, Health and Paramedicine - Kashan University of Medical Sciences</contact_name>
        <contact_address>Qutb Rawandi Blvd kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
