<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/NCT04462666</url>
  </required_header>
  <id_info>
    <org_study_id>2020024</org_study_id>
    <nct_id>NCT04462666</nct_id>
  </id_info>
  <brief_title>Oral Huzhang Granules for Acute Gouty Arthritis</brief_title>
  <official_title>Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Yueyang Integrated Medicine Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Yueyang Integrated Medicine Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We designed this study as a double-blind, randomized, controlled clinical trial. The aim of&#xD;
      the study is to evaluate the clinical efficacy, safety and control of recurrence rate of&#xD;
      acute gouty arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gout is a recurrent chronic inflammatory disease caused by monosodium urate (MSU) crystal .&#xD;
      Acute gouty arthritis (GA) is the most common first symptom of gout. With the progress of the&#xD;
      disease, the frequency of acute attack increases, and joint destruction may occur. The&#xD;
      prevalence of hyperuricemia in China was about 13.3%, and the pooled prevalence of gout was&#xD;
      1.1%. Repeated attacks of GA seriously affect the quality of life, resulting in huge economic&#xD;
      costs and mental stress. Due to inadequate prevention and treatment, the target of healing&#xD;
      gout is often not achieved. In GA, TCM has shown satisfactory therapeutic effect with less&#xD;
      adverse effects and minimal toxicity. Huzhang granule (HZG), a Chinese herbal prescription,&#xD;
      is a compound preparation with twelve ingredients which has been used in the clinical&#xD;
      treatment of gout for over 30 years at the Yueyang Hospital of Integrated Traditional Chinese&#xD;
      and Western Medicine affiliated to Shanghai University of TCM.Therefore，this double-blind,&#xD;
      randomized, controlled clinical trial. will provide high-quality clinical evidences for&#xD;
      evaluating the clinical efficacy, safety and control of recurrence rate of Huzhang granule ，a&#xD;
      representative prescription for the treatment of acute gouty arthritis , in the treatment of&#xD;
      GA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Score (VAS)</measure>
    <time_frame>Up to 5 days after treatment</time_frame>
    <description>Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Likert scales for the assessment of joint tenderness and swelling</measure>
    <time_frame>Up to 5 days after treatment</time_frame>
    <description>Likert scales for the assessment of joint tenderness and swelling is evaluate the inflammatory response and the degree of injury of the joint.Scores range from 1-5, a higher score indicating a severe symptoms on a participant's joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptom relief time</measure>
    <time_frame>Up to 5 days after treatment</time_frame>
    <description>Symptom relief time is the time when joint pain feels relieved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey</measure>
    <time_frame>Up to 5 days after treatment</time_frame>
    <description>36-Item Short Form Survey is a health status profile originally designed to measure eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.&#xD;
Scoring the 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key in a given table. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. another lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">267</enrollment>
  <condition>Gouty Arthritis</condition>
  <arm_group>
    <arm_group_label>HZG intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the 5-day treatment period, participants in the Experimental group will receive 10 sacks of experimental granules. They will be instructed to take two sacks per day, one in the morning and one in the evening, in approximately 30 minutes after the meal.. The placebo etoricoxib will also be taken daily in the morning for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etoricoxib intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the 5-day treatment period, participants in the Etoricoxib group will receive 5 Etoricoxib capsules. They will be instructed to take one capsule per day in the morning, at approximately 30 minutes after the meal. The placebo HZKL will also be taken daily in the morning for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the 5-day treatment period, participants in the Placebo group will receive 10 sacks of placebo HZG. They will be instructed to take two sacks per day, one sack in the morning and one in the evening, at approximately 30 minutes after the meal. And the placebo etoricoxib also be taken daily in the morning for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Huzhang granule</intervention_name>
    <description>Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.</description>
    <arm_group_label>HZG intervention</arm_group_label>
    <other_name>Chinese Herbal Medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoricoxib</intervention_name>
    <description>take one capsule per day in the morning, at approximately 30 minutes after the meal.</description>
    <arm_group_label>Etoricoxib intervention</arm_group_label>
    <other_name>Chemical drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Huzhang granule Placebo</intervention_name>
    <description>Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.</description>
    <arm_group_label>Etoricoxib intervention</arm_group_label>
    <arm_group_label>Placebo intervention</arm_group_label>
    <other_name>Chinese Herbal Medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoricoxib Placebo</intervention_name>
    <description>take one capsule per day in the morning, at approximately 30 minutes after the meal.</description>
    <arm_group_label>HZG intervention</arm_group_label>
    <arm_group_label>Placebo intervention</arm_group_label>
    <other_name>Chemical drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute gout arthritis as defined by the American College of Rheumatology&#xD;
             1977 preliminary criteria;&#xD;
&#xD;
          -  Male or non-pregnant, non-nursing female;&#xD;
&#xD;
          -  18-70 years of age;&#xD;
&#xD;
          -  Gout attack less ≤48 hours;&#xD;
&#xD;
          -  In the week before this observation, non-steroidal anti-inflammatory drugs and&#xD;
             analgesic drugs and drugs affecting uric acid metabolism were not taken;&#xD;
&#xD;
          -  Subjects capable of giving informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  failing to meet the diagnostic criteria;&#xD;
&#xD;
          -  Evidence of uncontrolled concomitant cardiovascular, nervous system,hepatic or&#xD;
             gastrointestinal disease. Potential participants who have active concomitant disease&#xD;
             can only be eligible after discussion and agreement with the treating medical team;&#xD;
&#xD;
          -  the patient is in critical condition and it is difficult to evaluate the effectiveness&#xD;
             and safety of the clinical observation;&#xD;
&#xD;
          -  severe deformity, stiffness and labor loss of patients with advanced arthritis;&#xD;
&#xD;
          -  known allergic to the drug used in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jia Zhou</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Yueyang Integrated Medicine Hospital, Shanghai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bin Li</last_name>
    <phone>0086-021-55981301</phone>
    <email>18930568129@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mi Zhou</last_name>
    <phone>0086-13636686022</phone>
    <email>vieky2866@163.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 5, 2020</last_update_submitted>
  <last_update_submitted_qc>July 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gouty arthritis</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Huzhang granule</keyword>
  <keyword>Traditional Chinese medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Gouty</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoricoxib</mesh_term>
  </intervention_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/NCT04462666
org study id: 2020024
nct id: NCT04462666
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We designed this study as a double-blind, randomized, controlled clinical trial. The aim of
      the study is to evaluate the clinical efficacy, safety and control of recurrence rate of
      acute gouty arthritis
Gout is a recurrent chronic inflammatory disease caused by monosodium urate (MSU) crystal .
      Acute gouty arthritis (GA) is the most common first symptom of gout. With the progress of the
      disease, the frequency of acute attack increases, and joint destruction may occur. The
      prevalence of hyperuricemia in China was about 13.3%, and the pooled prevalence of gout was
      1.1%. Repeated attacks of GA seriously affect the quality of life, resulting in huge economic
      costs and mental stress. Due to inadequate prevention and treatment, the target of healing
      gout is often not achieved. In GA, TCM has shown satisfactory therapeutic effect with less
      adverse effects and minimal toxicity. Huzhang granule (HZG), a Chinese herbal prescription,
      is a compound preparation with twelve ingredients which has been used in the clinical
      treatment of gout for over 30 years at the Yueyang Hospital of Integrated Traditional Chinese
      and Western Medicine affiliated to Shanghai University of TCM.Therefore，this double-blind,
      randomized, controlled clinical trial. will provide high-quality clinical evidences for
      evaluating the clinical efficacy, safety and control of recurrence rate of Huzhang granule ，a
      representative prescription for the treatment of acute gouty arthritis , in the treatment of
      GA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Score (VAS)
time frame: Up to 5 days after treatment
description: Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
measure: Likert scales for the assessment of joint tenderness and swelling
time frame: Up to 5 days after treatment
description: Likert scales for the assessment of joint tenderness and swelling is evaluate the inflammatory response and the degree of injury of the joint.Scores range from 1-5, a higher score indicating a severe symptoms on a participant's joint
measure: symptom relief time
time frame: Up to 5 days after treatment
description: Symptom relief time is the time when joint pain feels relieved
measure: 36-Item Short Form Survey
time frame: Up to 5 days after treatment
description: 36-Item Short Form Survey is a health status profile originally designed to measure eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Scoring the 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key in a given table. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. another lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating
arm group label: HZG intervention
arm group type: Experimental
description: During the 5-day treatment period, participants in the Experimental group will receive 10 sacks of experimental granules. They will be instructed to take two sacks per day, one in the morning and one in the evening, in approximately 30 minutes after the meal.. The placebo etoricoxib will also be taken daily in the morning for 5 days.
arm group label: Etoricoxib intervention
arm group type: Active Comparator
description: During the 5-day treatment period, participants in the Etoricoxib group will receive 5 Etoricoxib capsules. They will be instructed to take one capsule per day in the morning, at approximately 30 minutes after the meal. The placebo HZKL will also be taken daily in the morning for 5 days.
arm group label: Placebo intervention
arm group type: Placebo Comparator
description: During the 5-day treatment period, participants in the Placebo group will receive 10 sacks of placebo HZG. They will be instructed to take two sacks per day, one sack in the morning and one in the evening, at approximately 30 minutes after the meal. And the placebo etoricoxib also be taken daily in the morning for 5 days.
intervention type: Drug
intervention name: Huzhang granule
description: Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
arm group label: HZG intervention
other name: Chinese Herbal Medicine
intervention type: Drug
intervention name: Etoricoxib
description: take one capsule per day in the morning, at approximately 30 minutes after the meal.
arm group label: Etoricoxib intervention
other name: Chemical drug
intervention type: Drug
intervention name: Huzhang granule Placebo
description: Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
arm group label: Etoricoxib intervention
arm group label: Placebo intervention
other name: Chinese Herbal Medicine
intervention type: Drug
intervention name: Etoricoxib Placebo
description: take one capsule per day in the morning, at approximately 30 minutes after the meal.
arm group label: HZG intervention
arm group label: Placebo intervention
other name: Chemical drug
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jia Zhou
role: Study Chair
affiliation: Shanghai Yueyang Integrated Medicine Hospital, Shanghai
last name: Bin Li
phone: 0086-021-55981301
email: 18930568129@163.com
last name: Mi Zhou
phone: 0086-13636686022
email: vieky2866@163.com
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Gouty
mesh term: Etoricoxib
sharing ipd: Undecided