<?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>IRCT20150706023084N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Ganoderma lucidum on weight and chemical biomarkers and blood pressure in overweight people</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supplementation with Ganoderma lucidum on anthropometric indices,chemical biomarkers and blood pressure of people with overweight</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling was done by simple random sampling so that 72 people were selected using a random table of numbers and randomly assigned by random numbers by random numbers in Exel software were divided into two groups of intervention and control (default: numbers Pairs in Ganoderma supplement group = intervention group and individual numbers in group of capsules filled with wheat flour = in control group), Blinding description: All patients who were eligible for the study were randomly divided into placebo and drug groups. Patients and laboratory staff and physicians were unaware of the intervention drug or placebo. But the researcher knew whether the intervention was drug or placebo. And the drugs were coded by the researcher. The dressing was such that the placebo was the same shape, color, and taste of the drug. That is, the drug and the placebo were both similar in appearance. But the placebo capsules contained wheat flour.</study_design>
      <phase>3</phase>
      <hc_freetext>overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group received 3 Ganoderma supplement capsules per day, each capsule containing 220 mg of complete powder of Ganoderma lucidum and 30 mg of pure aqueous extract of Ganoderma lucidum. Intervention 2: Control group: This group received 3 capsules a day, each capsule containing 250 mg of wheat flour as a placebo.</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 It needs more research</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amine babamiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abuzar street</address>
        <city>Bukan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59518039574</zip>
        <telephone>0098 44 6247630</telephone>
        <email>dr.babamiri.shilan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>amineh babamiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>abuzar</address>
        <city>bukan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59518039574</zip>
        <telephone>0098 446247630</telephone>
        <email>dr.babamiri.shilan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an age of 18-60 years
personal satisfaction
BMI between 29.9-25
no underlying diseases interfering with weight loss and drug use
taking any type of weight loss and fat or blood pressure monitor and blood sugar controller
no pregnancy And breastfeeding</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking weight loss supplements
following a diet to lose weight
diseases related to metabolic changes such as thyroid disease
pregnancy and lactation,
taking drugs that inhibit platelet aggregation (such as aspirin or warfarin) due to drug interactions
unavailability of any a reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: This group received 3 Ganoderma supplement capsules per day, each capsule containing 220 mg of complete powder of Ganoderma lucidum and 30 mg of pure aqueous extract of Ganoderma lucidum.</i_keyword>
      <i_keyword>Control group: This group received 3 capsules a day, each capsule containing 250 mg of wheat flour as a placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body mass index (BMI). Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: math formula.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: digital Balance.</prim_outcome>
      <prim_outcome>Arm circumference. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Hip circumference. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Waist. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Waist to hip. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: math formula.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Direct enzymatic.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Direct enzymatic.</prim_outcome>
      <prim_outcome>High density lipoprotein (HDL). Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Direct enzymatic.</prim_outcome>
      <prim_outcome>Low density lipoprotein (LDL). Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Direct enzymatic.</prim_outcome>
      <prim_outcome>Blood sugar. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: Direct enzymatic.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: Before the start of the study and 42 days after starting to take Ganoderma capsules. Method of measurement: International Physical Activity Questionnaire (IPAQ).</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>2020-06-28</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Medical Sciences, Tehran</contact_name>
        <contact_address>Paint Factory Deadlock, Attari Moghadam St , Shahid Khaghani St , Islamic Azad University of Tehran Medical Branch , Research Office TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
