<?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>IRCT20200423047176N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Yoga Comparing to Amantadine   and Commitment Group Therapy in Patients with Multiple Sclerosis</public_title>
      <acronym>ACT</acronym>
      <scientific_title>Effectiveness of Yoga Comparing to Amantadine   and Commitment Group Therapy on Fatigue and Pain and Life Quality  in Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47463</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>MULTIPLE SCLEROSIS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1 Yoga Exercises: For 12 weeks and three sessions each week and each session for 75-60 minutes under the supervision of an experienced instructor. Asana (movement) exercises 40-35 minutes including stretching and softening exercises in all muscles of the body, pranayama exercises (breathing) 10-15 minutes including controlling the ratio of inhalation and exhalation, meditation (release) 15-20 minutes on a regular basis and focusing on a topic Special. Intervention 2: Intervention Group 2 Acceptance and Commitment Therapy Group for 12 Weeks a week 60-minute session under the supervision of a specialist who has all six components of treatment including admission, fault, self as field, mindfulness, enlightenment values ​​and commitment in The format of metaphors and exercises was taught. Intervention 3: Intervention group 3 Use of amantadine 100mg twice daily for three months (one every 12 hours).</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 data seems to be as clear as possible

When:
Start access three months after printing the results

To whom:
Researchers working in universities, scientific and medical centers

Conditions:
In order to be used for the well-being of patients with MS
Conditions: No change of content

Where to obtain:
I am Raheleh Rezaian Langroudi by e-mail r.r1351@yahoo.com or Hamadan Branch of Azad University, Department of Medical Sciences

How to obtain:
send mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raheleh Rezaeian Langroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masters of Kaj Boulevard Kaj Tower, 3rd floor, unit 6</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516873597</zip>
        <telephone>+98 81 3821 0047</telephone>
        <email>r.r1351@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Raheleh Rezaeian Langroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masters of Kaj Boulevard Kaj Tower, 3rd floor, unit 6</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516873597</zip>
        <telephone>+98 81 3821 0047</telephone>
        <email>r.r1351@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis based on neurological examinations and MRI
Symptoms of pain and fatigue that have been confirmed by interview and questionnaire
Patient dissatisfaction with their daily functioning
No other illness
Do not take other medications
No contraindications to amantadine</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Do not exercise regularly
Complications of amantadine
Hospitalization for any reason
death</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>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1 Yoga Exercises: For 12 weeks and three sessions each week and each session for 75-60 minutes under the supervision of an experienced instructor. Asana (movement) exercises 40-35 minutes including stretching and softening exercises in all muscles of the body, pranayama exercises (breathing) 10-15 minutes including controlling the ratio of inhalation and exhalation, meditation (release) 15-20 minutes on a regular basis and focusing on a topic Special.</i_keyword>
      <i_keyword>Intervention Group 2 Acceptance and Commitment Therapy Group for 12 Weeks a week 60-minute session under the supervision of a specialist who has all six components of treatment including admission, fault, self as field, mindfulness, enlightenment values ​​and commitment in The format of metaphors and exercises was taught.</i_keyword>
      <i_keyword>Intervention group 3 Use of amantadine 100mg twice daily for three months (one every 12 hours).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>People whose fatigue rate is determined by the Fatigue Severity Scale (9FSS) to a low to moderate to severe level. Timepoint: Amantadine 100mg treatment group twice daily for three months. Method of measurement: Fatigue Severity Scale(FSS-9).</prim_outcome>
      <prim_outcome>People whose pain rate is determined by the NRS (Numeric Pain Rating Scale) are low, medium, and severe. Timepoint: Yoga Exercise Group 12 weeks 3 sessions per week. Method of measurement: Numeric Pain Rating Scale(NRS).</prim_outcome>
      <prim_outcome>People whose quality of life is determined by the Multiple Sclerosis Impact Scale (MSIS-29). Timepoint: Acceptance and commitment group therapy group 12 hours a week one hour a week. Method of measurement: Multiple Sclerosis Impact Scale (MSIS-29).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Boroujerd Azad University Ethics Committee</contact_name>
        <contact_address>Yadan Nawab, Yadegar Imam St., Imam Khomeini University Complex Mailbox: 518 Boroujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
