<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/NCT01665651</url>
  </required_header>
  <id_info>
    <org_study_id>Kidney Yin/Yang replenishment</org_study_id>
    <nct_id>NCT01665651</nct_id>
  </id_info>
  <brief_title>Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy</brief_title>
  <official_title>Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bing Shu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huadong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Longhua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or&#xD;
      bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected&#xD;
      with decrease of renal function. In traditional Chinese medicine, kidney function is&#xD;
      considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment&#xD;
      will help improve bone development and metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study patients with chronic renal insufficiency and secondary osteoporosis or bone&#xD;
      loss will be evaluated with traditional Chinese medicine standard and allocated into kidney&#xD;
      Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be&#xD;
      divided into Zuogui granules treatment group and placebo group. In Yang deficiency group,&#xD;
      patients will be divided into Yuogui granules treatment group and placebo group. All the&#xD;
      patients will also accept basic treatment.&#xD;
&#xD;
      After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral&#xD;
      density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum&#xD;
      and urinal Ca, P. We will also perform miRNA array. The data before treatment and after&#xD;
      treatment will be compared. The data of treatment groups and placebo groups will also be&#xD;
      compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Hard to enroll participants&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kidney Yin and Yang evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Function of Kidney Yin and Yang will be evaluated with Traditional Chinese Medicine methods before and after treatment(Kidney Yin/Yang replenishment) to check whether function of Kidney Yin and Yang are improved.&#xD;
In Traditional Chinese Medicine, function of Kidney Yin and Yang are evaluated according to some specific symptoms and the severity including soreness of the waist and knee, exhausted, tinnitus, hard of hearing, hair loss, white hair, dizziness, dry mouth, red flush in face, night sweating, hot flashes, insomnia, dreaminess, the status of tongue body and coating and so on.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone metabolism</measure>
    <time_frame>3 months</time_frame>
    <description>bone alkaline phosphatase, fibroblast growth factor 23, Osteocalcin, Parathyroid hormone , 1,25(OH)2D3, serum and urinal Ca, P will be detected to check whether bone metabolism is improved after treatment(Kidney Yin/Yang replenishment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Urea Nitrogen</measure>
    <time_frame>3 months</time_frame>
    <description>BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>creatinine</measure>
    <time_frame>3 months</time_frame>
    <description>Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>miRNA array</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>bone morphogenetic protein 7</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Renal Osteodystrophy</condition>
  <arm_group>
    <arm_group_label>kidney Yin deficiency with placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kidney Yang deficiency with placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kidney Yin deficiency with Zuogui</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kidney Yang deficiency with Yougui</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yougui granules</intervention_name>
    <description>Yougui granules is traditional Chinese patent medicine used to treatment patients with kidney Yang deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.</description>
    <arm_group_label>kidney Yang deficiency with Yougui</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zuogui granules</intervention_name>
    <description>Zuogui granules is traditional Chinese patent medicine used to treatment patients with kidney Yin deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.</description>
    <arm_group_label>kidney Yin deficiency with Zuogui</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yougui granules placebo</intervention_name>
    <description>Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.</description>
    <arm_group_label>kidney Yang deficiency with placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zuogui granules placebo</intervention_name>
    <description>Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.</description>
    <arm_group_label>kidney Yin deficiency with placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic renal insufficiency&#xD;
&#xD;
          -  bone loss or osteoporosis&#xD;
&#xD;
          -  30-50 years old&#xD;
&#xD;
          -  kidney Yin or Yang deficiency evaluated with traditional Chinese medicine&#xD;
&#xD;
          -  be willing to and be able to join in the study and signed Informed consent&#xD;
&#xD;
          -  have not accepted systematical treatment on bone loss or osteoporosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergies&#xD;
&#xD;
          -  secondary osteoporosis caused by other diseases.&#xD;
&#xD;
          -  postmenopausal women&#xD;
&#xD;
          -  mental illness or psychosis&#xD;
&#xD;
          -  patients with bone fracture and need surgery treatment&#xD;
&#xD;
          -  taking any medicine that will affect bone metabolism for a long time and can not stop&#xD;
&#xD;
          -  women during pregnant stage and breast-feed stage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yongjun Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Longhua hospital affiliated to Shanghai Uni of TCM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The first affiliated hospital of Anhui University of TCM</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huadong hospital affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longhua Hospital affiliated to Shanghai Uni of TCM</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Bing Shu</investigator_full_name>
    <investigator_title>assistant research fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Kidney Disease-Mineral and Bone Disorder</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT01665651
org study id: Kidney Yin/Yang replenishment
nct id: NCT01665651
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or
      bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected
      with decrease of renal function. In traditional Chinese medicine, kidney function is
      considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment
      will help improve bone development and metabolism.
In this study patients with chronic renal insufficiency and secondary osteoporosis or bone
      loss will be evaluated with traditional Chinese medicine standard and allocated into kidney
      Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be
      divided into Zuogui granules treatment group and placebo group. In Yang deficiency group,
      patients will be divided into Yuogui granules treatment group and placebo group. All the
      patients will also accept basic treatment.

      After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral
      density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum
      and urinal Ca, P. We will also perform miRNA array. The data before treatment and after
      treatment will be compared. The data of treatment groups and placebo groups will also be
      compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bone Mineral Density
time frame: 3 months
measure: Kidney Yin and Yang evaluation
time frame: 3 months
description: Function of Kidney Yin and Yang will be evaluated with Traditional Chinese Medicine methods before and after treatment(Kidney Yin/Yang replenishment) to check whether function of Kidney Yin and Yang are improved.
In Traditional Chinese Medicine, function of Kidney Yin and Yang are evaluated according to some specific symptoms and the severity including soreness of the waist and knee, exhausted, tinnitus, hard of hearing, hair loss, white hair, dizziness, dry mouth, red flush in face, night sweating, hot flashes, insomnia, dreaminess, the status of tongue body and coating and so on.
measure: bone metabolism
time frame: 3 months
description: bone alkaline phosphatase, fibroblast growth factor 23, Osteocalcin, Parathyroid hormone , 1,25(OH)2D3, serum and urinal Ca, P will be detected to check whether bone metabolism is improved after treatment(Kidney Yin/Yang replenishment).
measure: Blood Urea Nitrogen
time frame: 3 months
description: BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
measure: creatinine
time frame: 3 months
description: Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
measure: miRNA array
time frame: 3 months
measure: bone morphogenetic protein 7
time frame: 3 months
arm group label: kidney Yin deficiency with placebo
arm group type: Placebo Comparator
description: chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.
arm group label: kidney Yang deficiency with placebo
arm group type: Placebo Comparator
description: chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.
arm group label: kidney Yin deficiency with Zuogui
arm group type: Experimental
description: chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.
arm group label: kidney Yang deficiency with Yougui
arm group type: Experimental
description: chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.
intervention type: Drug
intervention name: Yougui granules
description: Yougui granules is traditional Chinese patent medicine used to treatment patients with kidney Yang deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
arm group label: kidney Yang deficiency with Yougui
intervention type: Drug
intervention name: Zuogui granules
description: Zuogui granules is traditional Chinese patent medicine used to treatment patients with kidney Yin deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
arm group label: kidney Yin deficiency with Zuogui
intervention type: Drug
intervention name: Yougui granules placebo
description: Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
arm group label: kidney Yang deficiency with placebo
intervention type: Drug
intervention name: Zuogui granules placebo
description: Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
arm group label: kidney Yin deficiency with placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yongjun Wang, Doctor
role: Principal Investigator
affiliation: Longhua hospital affiliated to Shanghai Uni of TCM
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai University of Traditional Chinese Medicine
investigator full name: Bing Shu
investigator title: assistant research fellow
mesh term: Chronic Kidney Disease-Mineral and Bone Disorder
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic