<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/NCT02981732</url>
  </required_header>
  <id_info>
    <org_study_id>81674007</org_study_id>
    <nct_id>NCT02981732</nct_id>
  </id_info>
  <brief_title>CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome</brief_title>
  <acronym>PMOP</acronym>
  <official_title>CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome Regulating the Bone Osteoimmunology Mechanism by the OPG/RANKL/RANK Signal System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>xuhuijuan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Academy of Traditional Chinese Medicine</source>
  <brief_summary>
    <textblock>
      For nearly 112 million patients with osteoporosis in China, it is of great significance for&#xD;
      preventing and treating by clearly understanding the molecular mechanism of kidney&#xD;
      deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is&#xD;
      an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for&#xD;
      kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of&#xD;
      the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe&#xD;
      impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system&#xD;
      using the technology of adenovirus associated virus. ②explore impacts of over-expression and&#xD;
      silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③&#xD;
      analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon&#xD;
      immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism&#xD;
      by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism,&#xD;
      so as to demonstrate if the hypothesis of this study that &quot;the molecular osteoimmunological&#xD;
      mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely&#xD;
      related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone&#xD;
      metabolism&quot; is right or not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>osteoporosis treatment within six months of study enrollment</measure>
    <time_frame>Liuwei Dihuang Pills therapy(up to six months)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Postmenopausal Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Shen (Kidney) yin deficiency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shen (Kidney) yin deficiency</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the control group,there is no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Liuwei Dihuang Pill</intervention_name>
    <arm_group_label>Shen (Kidney) yin deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were included if they were female Han Chinese patients who had undergone&#xD;
             natural menopause at least 2 years prior and&#xD;
&#xD;
               -  met the diagnostic criteria for osteoporosis according to the &quot;clinical practice&#xD;
                  guidelines of traditional medicine for primary osteoporosis&quot;&#xD;
&#xD;
               -  met the CM diagnostic criteria according to &quot;Syndrome Differentiation in Modern&#xD;
                  Research of Traditional Chinese Medicine&quot;&#xD;
&#xD;
               -  provided informed consent, which was approved by the Fujian Academy of&#xD;
                  Traditional Chinese Medicine Clinical Research Ethics Committee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who did not meet the diagnostic criteria for osteoporosis or CM standards&#xD;
&#xD;
          -  patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to&#xD;
             hyperthyroidism, and severe cardiovascular or cerebrovascular diseases&#xD;
&#xD;
          -  patients with abnormal liver and/or Shen function test results&#xD;
&#xD;
          -  patients with osteoporosis who had received treatment with CM within the last month,&#xD;
             hormone replacement therapy and calcitonin within the past three months, or&#xD;
             bisphosphonates for 15 consecutive days within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>46 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yao xin</last_name>
    <phone>0591-83570813</phone>
    <email>yjyllbgs@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fujian Academy of Trational Chiness Medicine</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao xin</last_name>
      <phone>0591-83570813</phone>
      <email>yjyllbgs@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 24, 2017</last_update_submitted>
  <last_update_submitted_qc>March 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Academy of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>xuhuijuan</investigator_full_name>
    <investigator_title>Fujian Academy of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <keyword>Osteoporosis</keyword>
  <keyword>kidney yin deficiency syndrome</keyword>
  <keyword>liuwei dihuang pill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Yin Deficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT02981732
org study id: 81674007
nct id: NCT02981732
lead sponsor: 
For nearly 112 million patients with osteoporosis in China, it is of great significance for
      preventing and treating by clearly understanding the molecular mechanism of kidney
      deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is
      an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for
      kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of
      the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe
      impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system
      using the technology of adenovirus associated virus. ②explore impacts of over-expression and
      silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③
      analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon
      immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism
      by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism,
      so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological
      mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely
      related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone
      metabolism" is right or not.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: osteoporosis treatment within six months of study enrollment
time frame: Liuwei Dihuang Pills therapy(up to six months)
arm group label: Shen (Kidney) yin deficiency
arm group type: Experimental
description: Shen (Kidney) yin deficiency
arm group label: the control group
arm group type: No Intervention
description: the control group,there is no intervention
intervention type: Other
intervention name: Liuwei Dihuang Pill
arm group label: Shen (Kidney) yin deficiency
criteria: 
gender: Female
minimum age: 46 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yao xin
phone: 0591-83570813
email: yjyllbgs@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fujian Academy of Traditional Chinese Medicine
investigator full name: xuhuijuan
investigator title: Fujian Academy of Traditional Chinese Medicine
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Yin Deficiency