<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718548</url>
  </required_header>
  <id_info>
    <org_study_id>0062-12-HYMC</org_study_id>
    <nct_id>NCT01718548</nct_id>
  </id_info>
  <brief_title>The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many&#xD;
      years for treatment of a variety of conditions. The aim of this study is to evaluate the&#xD;
      effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on&#xD;
      cardiopulmonary fitness and cognitive functioning in young, healthy physical education&#xD;
      students.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts</measure>
    <time_frame>28 days</time_frame>
    <description>Before and after 28-day ingestion of CS and Lingzhi extracts, subjects will undergo a graded exercise test on a treadmill and results will be compared.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Effect of CS and Lingzhi on Cognitive Functioning</measure>
    <time_frame>28 days</time_frame>
    <description>Before and after 28-day ingestion of CS and Lingzhi the subjects undergo computerized cognitive tests and results will be compared.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Physical Fitness</condition>
  <condition>Executive Function</condition>
  <arm_group>
    <arm_group_label>CS and Lingzhi</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CS liquid (each dosage is a bottle of liquid containing 30 ml: comprising 75% of CS, 6% Lingzhi, 6% shitake, 5% bamboo shoot, 2% honey, 0.1% potassium sorbet and 5.9% pure water) and Lingzhi capsule (each capsule contains 620mg of: 52.42% Lingzhi, 28.23% CS, and 19.35% soy gel ) ; one quarter bottle of CS to be ingested twice a day, and the Lingzhi capsule to be taken once a day, both for a period of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Liquid tea ingested twice a day and flour-filled capsules ingested once a day over a period of 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cordyceps Sinensis (CS) and Lingzhi</intervention_name>
    <arm_group_label>CS and Lingzhi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tea and Flour</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical education students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wingate Institute</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Sharon Tsuk, PhD</last_name>
      <phone>09-8639235</phone>
      <email>sharontsuk1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sharon Tsuk, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718548
org study id: 0062-12-HYMC
nct id: NCT01718548
lead sponsor: 
has dmc: Yes
Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many
      years for treatment of a variety of conditions. The aim of this study is to evaluate the
      effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on
      cardiopulmonary fitness and cognitive functioning in young, healthy physical education
      students.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts
time frame: 28 days
description: Before and after 28-day ingestion of CS and Lingzhi extracts, subjects will undergo a graded exercise test on a treadmill and results will be compared.
measure: Effect of CS and Lingzhi on Cognitive Functioning
time frame: 28 days
description: Before and after 28-day ingestion of CS and Lingzhi the subjects undergo computerized cognitive tests and results will be compared.
arm group label: CS and Lingzhi
arm group type: Active Comparator
description: CS liquid (each dosage is a bottle of liquid containing 30 ml: comprising 75% of CS, 6% Lingzhi, 6% shitake, 5% bamboo shoot, 2% honey, 0.1% potassium sorbet and 5.9% pure water) and Lingzhi capsule (each capsule contains 620mg of: 52.42% Lingzhi, 28.23% CS, and 19.35% soy gel ) ; one quarter bottle of CS to be ingested twice a day, and the Lingzhi capsule to be taken once a day, both for a period of 28 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Liquid tea ingested twice a day and flour-filled capsules ingested once a day over a period of 28 days
intervention type: Dietary Supplement
intervention name: Cordyceps Sinensis (CS) and Lingzhi
arm group label: CS and Lingzhi
intervention type: Dietary Supplement
intervention name: Tea and Flour
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor