<?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>IRCT20200708048053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Ganoderma Leucidum Extract and Eight-Week Endurance Exercise on Selection of Antioxidant Indicators and Growth Factors and Nervous Mediators in Parkinson's Old Men</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Ganoderma Leucidum Extract and Eight-Week Endurance Exercise on Selection of Antioxidant Indicators and Growth Factors and Nervous Mediators in Parkinson's Old Men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Simultaneous intervention of exercise and Ganoderma extract was applied to Parkinson's patients, Randomization description: Random assignment to intervention and control groups
The randomization method is simple randomization and the randomization unit is individual. Randomization and random sequencing will be performed using a web-based randomization system (/https://www.graphpad.com/quickcalcs/randMenu). Hide group assignments will be done using numbered consecutive sealed envelopes.</study_design>
      <phase>2</phase>
      <hc_freetext>Parkinson.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 6 Parkinson's male patients- No intervention will be performed in the control group. Intervention 2: Intervention group: Training group of 6 patients with Parkinson's disease- The 8-week training program will be supervised three times a week under the supervision of a sports physiologist. Endurance training includes walking at a speed of 4 km / h to 8 km / h with an intensity of 50 to 65% of the maximum heart rate, the first 10 minutes will include warming up the main muscles of the body and the last 10 minutes will be considered as recovery. One week before the training contract, the objectives and method of conducting the research will be clearly explained to the subjects and then special consent forms will be provided to them. After entering the gym, the subjects will start warming up for 10 minutes. Which includes doing stretching movements. Subjects will then begin to walk at a speed of 4 km / h with an intensity of 50% of maximum heart rate. The intensity and duration of the activity will gradually increase, depending on the ability of the patients, so that in the 12th week, the walking speed will reach 8 km / h with a maximum intensity of 65% of the heart rate. At the end of the training session, a general cooling will be performed for 10 minutes. Intervention 3: Intervention group: Supplement (Ganoderma extract) 6 Parkinson's male - Intervention group: Supplement (Ganoderma lucidum extract) 6 patients with Parkinson's disease - Ganoderma lucidum extract manufactured by Bayes company and approved by the Food and Drug Administration and prepared according to the weight of individuals (Supplementary group: 6 mg Ganoderma lucidum powder per kg of body weight) So that the amount of Ganoderma consumed in the present study, according to the results of previous studies (Zee Liren et al., 2018) in the effective range (3-9 mg per kg of body weight, 30-60 minutes before the training contract) Will be required to improve the plasma level and performance of the subjects.patients. Intervention 4: Intervention group: Exercise + Supplement 6 Parkinson's male patients - They will do an endurance training program for eight weeks and three sessions per week - Ganoderma lucidum extract made by Bayes company and approved by the Food and Drug Administration and prepared according to weight Individuals (supplement group: 6 mg Ganoderma lucidum powder per kilogram of body weight) will be given to the subjects 45 minutes before the training contract. So that the amount of Ganoderma consumed in the present study, according to the results of previous studies (Zee Liren et al., 2018) in the effective range (3-9 mg per kg of body weight, 30-60 minutes before the training contract) Will be required to improve the plasma level and performance of the subjects.</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:
Total potential data after unrecognizable shared people
It's laying.

When:
Start the access period 6 months after printing the results

To whom:
Data will only be available to researchers working at academic and scientific institutions.

Conditions:
Various analyzes are allowed for researchers working in academic and scientific institutions.

Where to obtain:
Farshid Ganji - Ardabil Province - Meshkinshahr - Jomhouri St. in front of Etka Store - 09144580525 - 5661844347 - ganji.farshi1@gmail.com

How to obtain:
Send a request via email - Data submission time: two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshid Ganji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St Jomhori</address>
        <city>Meshkin Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5661844347</zip>
        <telephone>+98 45 3254 4375</telephone>
        <email>ganji.farshid1@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Barari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amol - 5 km of the old road from Amol to Babol - University Branch - Islamic Azad University, Ayatollah Amoli Branch</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>678</zip>
        <telephone>+98 11 4321 7000</telephone>
        <email>Alireza54.barari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Using Parkinson's, which can be told by a doctor for 3 years at level 3, you can measure Y&amp;H.
at level 3, you can measure Y&amp;H.
Be in the age range of 40-60 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients who were unable to perform their daily activities</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>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 6 Parkinson's male patients- No intervention will be performed in the control group</i_keyword>
      <i_keyword>Intervention group: Training group of 6 patients with Parkinson's disease- The 8-week training program will be supervised three times a week under the supervision of a sports physiologist. Endurance training includes walking at a speed of 4 km / h to 8 km / h with an intensity of 50 to 65% of the maximum heart rate, the first 10 minutes will include warming up the main muscles of the body and the last 10 minutes will be considered as recovery. One week before the training contract, the objectives and method of conducting the research will be clearly explained to the subjects and then special consent forms will be provided to them. After entering the gym, the subjects will start warming up for 10 minutes. Which includes doing stretching movements. Subjects will then begin to walk at a speed of 4 km / h with an intensity of 50% of maximum heart rate. The intensity and duration of the activity will gradually increase, depending on the ability of the patients, so that in the 12th week, the walking speed will reach 8 km / h with a maximum intensity of 65% of the heart rate. At the end of the training session, a general cooling will be performed for 10 minutes.</i_keyword>
      <i_keyword>Intervention group: Supplement (Ganoderma extract) 6 Parkinson's male - Intervention group: Supplement (Ganoderma lucidum extract) 6 patients with Parkinson's disease - Ganoderma lucidum extract manufactured by Bayes company and approved by the Food and Drug Administration and prepared according to the weight of individuals (Supplementary group: 6 mg Ganoderma lucidum powder per kg of body weight) So that the amount of Ganoderma consumed in the present study, according to the results of previous studies (Zee Liren et al., 2018) in the effective range (3-9 mg per kg of body weight, 30-60 minutes before the training contract) Will be required to improve the plasma level and performance of the subjects.patients</i_keyword>
      <i_keyword>Intervention group: Exercise + Supplement 6 Parkinson's male patients - They will do an endurance training program for eight weeks and three sessions per week - Ganoderma lucidum extract made by Bayes company and approved by the Food and Drug Administration and prepared according to weight Individuals (supplement group: 6 mg Ganoderma lucidum powder per kilogram of body weight) will be given to the subjects 45 minutes before the training contract. So that the amount of Ganoderma consumed in the present study, according to the results of previous studies (Zee Liren et al., 2018) in the effective range (3-9 mg per kg of body weight, 30-60 minutes before the training contract) Will be required to improve the plasma level and performance of the subjects.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antioxidant indicators (total antioxidant capacity)  in men with Parkinson's disease. Timepoint: 24 hours before the intervention and 24hours after the sports and medical intervention. Method of measurement: Serum level of total antioxidant capacity using TAC assay laboratory kit made by Pars Azmon Company and ELISA method.</prim_outcome>
      <prim_outcome>Plasma neuronal levels (NGF factor, dopamine, serotonin, BDNF, tyrosine hydroxylase) in men with Parkinson's. Timepoint: 24 hours before the intervention and 24hours after the sports and medical intervention. Method of measurement: 1. NGF factor by ELISA method and using special NGF Elisa Kit made in China with a sensitivity of 2.48 picograms per ml A2. Dopamine by ELISA method using LDN kit made by Pars Azmoun Company of Iran 3. Tyrosine hydroxylase level by ELISA method and by laboratory kit of Pars Azmoun Company of Iran 4. BDNF factor by ELISA method and using special kit (Human BDNF) Made in China with a sensitivity of 2 picograms per milliliter 5. Serotonin by ELISA method and LSD kit made by Pars Azmoun Company in Iran.</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>2020-06-09</approval_date>
        <contact_name>Islamic Azad University - Marvdasht</contact_name>
        <contact_address>ST Takht Jamshid Marvdasht Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
