<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/NCT04480359</url>
  </required_header>
  <id_info>
    <org_study_id>Bawei Shenqi Pill</org_study_id>
    <nct_id>NCT04480359</nct_id>
  </id_info>
  <brief_title>Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis</brief_title>
  <official_title>The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</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>
      The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the&#xD;
      treatment of active ankylosing spondylitis (AS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ankylosing spondylitis is a chronic inflammatory disease, which mainly invades sacroiliac&#xD;
      joint, spinal osteoid process, paraspinal soft tissue and peripheral joints, and can be&#xD;
      accompanied by extraarticular manifestations, in severe cases, spinal deformity and ankylosis&#xD;
      can occur. The overall prevalence rate of ankylosing spondylitis in China is about 0.3%, the&#xD;
      peak of which is 20 to 30 years old. although the prevalence rate is not high, the disability&#xD;
      rate is high, and the patients with ankylosing spondylitis are mainly young people of&#xD;
      childbearing age, which are in a critical period of work and study. If the disease can not be&#xD;
      controlled smoothly, it will seriously affect its learning and work efficiency, image&#xD;
      appearance and even the ability of daily life.&#xD;
&#xD;
      Bawei Shenqi Pill originates from Zhang Zhongjing's synopsis of the Golden Chamber, is the&#xD;
      representative prescription of warming and tonifying kidney yang, and is also suitable for&#xD;
      the pathogenesis of ankylosing spondylitis &quot;deficiency of kidney yang&quot;. The purpose of this&#xD;
      study was to observe the therapeutic effect of Bawei Shenqi Pill on ankylosing spondylitis of&#xD;
      kidney-yang deficiency type through a randomized controlled clinical study. To clarify the&#xD;
      effect of Bawei Shenqi Pill on disease activity, joint function, TCM syndrome integral and&#xD;
      quality of life in patients with ankylosing spondylitis, and to provide basis for the&#xD;
      treatment of ankylosing spondylitis with Bawei Shenqi Pill.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BASDAI</measure>
    <time_frame>12weeks</time_frame>
    <description>Bath Ankylosing Spondylitis Disease Activity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BASFI</measure>
    <time_frame>12weeks</time_frame>
    <description>Bath Ankylosing Spondylitis Functional Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRP</measure>
    <time_frame>12weeks</time_frame>
    <description>C-reactive protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ESR</measure>
    <time_frame>12weeks</time_frame>
    <description>Erythrocyte sedimentation rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>12weeks</time_frame>
    <description>occipital wall distance, chest expansion distance, finger ground distance, Schober test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>at baseline and at 3 months</time_frame>
    <description>SF- 36 scale for quality of life assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Bawei Shenqi group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>participants should administrate both Bawei Shenqi Pill and Meloxicam tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bawei Shenqi Pill</intervention_name>
    <description>5.1g, once a day, 3month, oral</description>
    <arm_group_label>Bawei Shenqi group</arm_group_label>
    <other_name>Experimental:Bawei Shenqi group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bawei Shenqi Pill placebo</intervention_name>
    <description>5.1g, once a day, 3month, oral</description>
    <arm_group_label>placebo group</arm_group_label>
    <other_name>Placebo Comparator: placebo group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meloxicam</intervention_name>
    <description>7.5mg, once a day, 3 month, oral</description>
    <arm_group_label>Bawei Shenqi group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
    <other_name>Experimental:Bawei Shenqi group</other_name>
    <other_name>Placebo Comparator: placebo group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Compliance with New York standards revised in 1984&#xD;
&#xD;
          -  Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang&#xD;
&#xD;
          -  18 to 70 years of age, male and female&#xD;
&#xD;
          -  Being able to understand or sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing&#xD;
             spondylitis, and TCM syndrome differentiation does not belong to kidney-yang&#xD;
             deficiency type.&#xD;
&#xD;
          -  Age is out of range&#xD;
&#xD;
          -  Do not agree to participate in this topic or can not participate in the whole process&#xD;
&#xD;
          -  Complicated with other rheumatic diseases or other seronegative spondyloarthropathy.&#xD;
&#xD;
          -  Pregnant, lactating women and patients with serious visceral diseases, mental&#xD;
             disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney&#xD;
             or hematopoietic system.&#xD;
&#xD;
          -  Have had myocardial infarction or stroke, congestive heart failure and active&#xD;
             digestive tract ulcer patients.&#xD;
&#xD;
          -  Those who had received other research drugs three months before screening.&#xD;
&#xD;
          -  Inability or unwillingness to provide informed consent or failure to comply with test&#xD;
             requirements.&#xD;
&#xD;
          -  The researchers believe that it is not suitable for the owners of the 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_contact>
    <last_name>Jianchun Mao, master</last_name>
    <phone>86-18917763231</phone>
    <email>mjcct2018@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianchun Mao, master</last_name>
      <phone>86-18917763231</phone>
      <email>mjcct2018@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>maojianchun</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Bawei Shenqi Pill</keyword>
  <keyword>ankylosing spondylitis</keyword>
  <keyword>clinical research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meloxicam</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/NCT04480359
org study id: Bawei Shenqi Pill
nct id: NCT04480359
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the
      treatment of active ankylosing spondylitis (AS).
Ankylosing spondylitis is a chronic inflammatory disease, which mainly invades sacroiliac
      joint, spinal osteoid process, paraspinal soft tissue and peripheral joints, and can be
      accompanied by extraarticular manifestations, in severe cases, spinal deformity and ankylosis
      can occur. The overall prevalence rate of ankylosing spondylitis in China is about 0.3%, the
      peak of which is 20 to 30 years old. although the prevalence rate is not high, the disability
      rate is high, and the patients with ankylosing spondylitis are mainly young people of
      childbearing age, which are in a critical period of work and study. If the disease can not be
      controlled smoothly, it will seriously affect its learning and work efficiency, image
      appearance and even the ability of daily life.

      Bawei Shenqi Pill originates from Zhang Zhongjing's synopsis of the Golden Chamber, is the
      representative prescription of warming and tonifying kidney yang, and is also suitable for
      the pathogenesis of ankylosing spondylitis "deficiency of kidney yang". The purpose of this
      study was to observe the therapeutic effect of Bawei Shenqi Pill on ankylosing spondylitis of
      kidney-yang deficiency type through a randomized controlled clinical study. To clarify the
      effect of Bawei Shenqi Pill on disease activity, joint function, TCM syndrome integral and
      quality of life in patients with ankylosing spondylitis, and to provide basis for the
      treatment of ankylosing spondylitis with Bawei Shenqi Pill.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: BASDAI
time frame: 12weeks
description: Bath Ankylosing Spondylitis Disease Activity Index
measure: BASFI
time frame: 12weeks
description: Bath Ankylosing Spondylitis Functional Index
measure: CRP
time frame: 12weeks
description: C-reactive protein
measure: ESR
time frame: 12weeks
description: Erythrocyte sedimentation rate
measure: Range of motion
time frame: 12weeks
description: occipital wall distance, chest expansion distance, finger ground distance, Schober test
measure: SF-36
time frame: at baseline and at 3 months
description: SF- 36 scale for quality of life assessment
arm group label: Bawei Shenqi group
arm group type: Active Comparator
description: participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
arm group label: placebo group
arm group type: Placebo Comparator
description: participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
intervention type: Drug
intervention name: Bawei Shenqi Pill
description: 5.1g, once a day, 3month, oral
arm group label: Bawei Shenqi group
other name: Experimental:Bawei Shenqi group
intervention type: Drug
intervention name: Bawei Shenqi Pill placebo
description: 5.1g, once a day, 3month, oral
arm group label: placebo group
other name: Placebo Comparator: placebo group
intervention type: Drug
intervention name: Meloxicam
description: 7.5mg, once a day, 3 month, oral
arm group label: Bawei Shenqi group
arm group label: placebo group
other name: Experimental:Bawei Shenqi group
other name: Placebo Comparator: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianchun Mao, master
phone: 86-18917763231
email: mjcct2018@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai University of Traditional Chinese Medicine
investigator full name: maojianchun
investigator title: professor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Meloxicam
sharing ipd: Undecided