<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/NCT04438486</url>
  </required_header>
  <id_info>
    <org_study_id>2019-411</org_study_id>
    <nct_id>NCT04438486</nct_id>
  </id_info>
  <brief_title>Effects of Barley Green in Patients With Hyperuricemia</brief_title>
  <official_title>Effects of Barley Green in Patients With Hyperuricemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jinhua Municipal Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quzhou Kecheng People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Shijitan Hospital, Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and&#xD;
      explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids,&#xD;
      blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be&#xD;
      randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm&#xD;
      B will receive dietary guidance and Barley Green.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>uric acid level</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Dietary Supplement</condition>
  <arm_group>
    <arm_group_label>dietary advice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>dietary advice+ Barely Green</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group A</intervention_name>
    <description>specific dietary advice for Hyperuricemia</description>
    <arm_group_label>dietary advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Group B</intervention_name>
    <description>Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A</description>
    <arm_group_label>dietary advice+ Barely Green</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years old those who are willing to accept assessment and sign informed&#xD;
             consent.&#xD;
&#xD;
          -  Under the normal purine diet, two fasting blood uric acid levels on different days:&#xD;
             420umol/l &lt;blood uric acid &lt;540 umol/l (male), 360 umol/l &lt;blood uric acid &lt;540 umol/l&#xD;
             (female)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently receiving treatment for hyperuricemia；&#xD;
&#xD;
          -  Suffering from diseases that affect the digestion and absorption(such as chronic&#xD;
             diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal&#xD;
             ulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.)；&#xD;
&#xD;
          -  Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension,&#xD;
             chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders,&#xD;
             epilepsy and other diseases;&#xD;
&#xD;
          -  At the same time receive other functional food nutrition support (plant active&#xD;
             substances, health food);&#xD;
&#xD;
          -  Patients with abnormal liver function (alanine aminotransferase or/and aspartate&#xD;
             aminotransferase exceeds 3 times the upper limit of normal value); patients with&#xD;
             abnormal renal function (serum creatinine exceeds the upper limit of normal value)；&#xD;
&#xD;
          -  Suffering from infectious diseases such as active tuberculosis and AIDS;&#xD;
&#xD;
          -  People who are severely allergic to the ingredients of research；&#xD;
&#xD;
          -  During pregnancy or lactation;&#xD;
&#xD;
          -  Patients with physical disabilities and clinicians think it is not suitable to&#xD;
             participate in the study (for example, suffering from serious diseases not included in&#xD;
             the discharge criteria)；&#xD;
&#xD;
          -  Gouty arthritis attack ≥ 2 times;&#xD;
&#xD;
          -  One episode of gouty arthritis with blood uric acid &gt;480 umol/l, or any of the&#xD;
             following: age &lt;40 years old, evidence of gout stone or urate deposition in the joint&#xD;
             cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)),&#xD;
             hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary&#xD;
             heart disease, stroke, cardiac insufficiency;&#xD;
&#xD;
          -  Blood uric acid&gt;480 umol/l combined with any of the following: uric acid&#xD;
             nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired&#xD;
             glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke,&#xD;
             heart failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pianhong Zhang, MS</last_name>
    <phone>+86057187783852</phone>
    <email>zrlcyyzx@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoxu Huang, MS</last_name>
    <phone>+8618067961987</phone>
    <email>xiaoxuhuang0909@zju.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pianhong Zhang, MD</last_name>
      <phone>+86 057187783852</phone>
      <email>zrlcyyzx@zju.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang cancer hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sa Ye</last_name>
      <phone>057188122222</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinhua municipal central hospital</name>
      <address>
        <city>Jinhua</city>
        <state>Zhejiang</state>
        <zip>321000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guifen Hu</last_name>
      <phone>057982338512</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Quzhou Kecheng People's Hospital</name>
      <address>
        <city>Quzhou</city>
        <state>Zhejiang</state>
        <zip>324000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qiuxia Chen</last_name>
      <phone>05708877120</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Wenzhou medical university</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binbin Gu</last_name>
      <phone>057755578033</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Shijitan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>Beijing</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanping Shi</last_name>
      <phone>01063926617</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperuricemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04438486
org study id: 2019-411
nct id: NCT04438486
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and
      explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids,
      blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be
      randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm
      B will receive dietary guidance and Barley Green.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: uric acid level
time frame: 3 months
arm group label: dietary advice
arm group type: Active Comparator
arm group label: dietary advice+ Barely Green
arm group type: Experimental
intervention type: Behavioral
intervention name: Group A
description: specific dietary advice for Hyperuricemia
arm group label: dietary advice
intervention type: Dietary Supplement
intervention name: Group B
description: Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A
arm group label: dietary advice+ Barely Green
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pianhong Zhang, MS
phone: +86057187783852
email: zrlcyyzx@zju.edu.cn
last name: Xiaoxu Huang, MS
phone: +8618067961987
email: xiaoxuhuang0909@zju.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hyperuricemia
sharing ipd: Undecided