<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/NCT03245710</url>
  </required_header>
  <id_info>
    <org_study_id>N201602096</org_study_id>
    <nct_id>NCT03245710</nct_id>
  </id_info>
  <brief_title>To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.</brief_title>
  <official_title>To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang 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>
      This study investigates the efficacy and mechanism of traditional Chinese medicine formula&#xD;
      power product in the treatment of osteopenia in patients with pain. Half of participants will&#xD;
      receive Chinese medicine formula power product, while the other half will receive a placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoporosis is a major public health problem, resulting in potentially pain and increasing&#xD;
      risk of fracture. Treatment of osteoporosis consists of pharmacotherapy, lifestyle measures,&#xD;
      dietary changes, mineral supplementation. Traditional Chinese medicine is a major component&#xD;
      of health care in Taiwan and provides one treatment alternative for osteoporosis.&#xD;
&#xD;
      Investigators investigate the efficacy and mechanism of traditional Chinese medicine formula&#xD;
      powder product in the treatment of osteopenia patients with pain.This trial is a 12 weeks'&#xD;
      randomized, placebo-controlled study. The study was approved by the Wan Fang hospital, and&#xD;
      signed informed consent was obtained from each participant. 80 Osteopenia participants with&#xD;
      pain were enrolled in this study. There were 80 participants aged 50 years or older included.&#xD;
      Before random assignment to treatment, participants were at least moderate pain during 2&#xD;
      weeks as identified by visual analogue scale (VAS) for more than 4. Bone mineral density&#xD;
      (BMD) of all participants was -2.5 or below without diabetes, hyperthyroidism,&#xD;
      hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis,&#xD;
      bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever&#xD;
      used steroids more than 3 week before assignment to treatment, Primary outcome measures were&#xD;
      the change of VAS scale, Oswestry Disability Index and WHOQOL-BREF Taiwan at week 1 and 12.&#xD;
      Secondary outcome was the genetic loci associated with a susceptibility to osteoprosis&#xD;
      treated by traditional Chinese medicine formula powder product.&#xD;
&#xD;
      Result : To provide evidence of the efficacy and mechanisms of ZBP powder product in the&#xD;
      treatment of osteoporosis patients with pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">March 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 7, 2020</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>Pain on the visual-analogue scales (VAS) for back and legs.</measure>
    <time_frame>baseline and week 12</time_frame>
    <description>A VAS is a 100-mm-long horizontal line that is anchored by word descriptors at each end (no pain and worst pain possible). The patient selects the point on the line that best represents his or her perception of their pain level.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Osteopenia</condition>
  <arm_group>
    <arm_group_label>Zhibai Dihuang powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm: Experimental: Zhibai Dihuang Formula powder Zhibai Dihuang Formula powder: Traditional Chinese medicine formula powder product 5g by mouth, after meal, 3 times in one day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>starch</description>
    <arm_group_label>placebos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Zhibai Dihuang powder</intervention_name>
    <description>the Traditional Chinese Medicine Formula Powder Product</description>
    <arm_group_label>Zhibai Dihuang powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 50 years or older.&#xD;
&#xD;
          2. VAS score≧4.0 in a week.&#xD;
&#xD;
          3. bone mineral density (BMD) of all participants was -2.5 or below.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diabetes.&#xD;
&#xD;
          2. thyroidism function disorder.&#xD;
&#xD;
          3. parathyroidism function disorder.&#xD;
&#xD;
          4. liver or kidney function disorder.&#xD;
&#xD;
          5. ovariectomy&#xD;
&#xD;
          6. rheumatoid arthritis.&#xD;
&#xD;
          7. bone cancer.&#xD;
&#xD;
          8. ever used hormone agent within 6 months before assignment to treatment.&#xD;
&#xD;
          9. ever used steroids more than 3 months before assignment to treatment.&#xD;
&#xD;
         10. ever used analgesics, excepted acetaminophen, more than 1 week before assignment to&#xD;
             treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chung-Yu Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Municipal WanFang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chung-Yu Huang, MD</last_name>
    <phone>+886-29307930</phone>
    <phone_ext>1710</phone_ext>
    <email>hcy@tmu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>WanFangH</name>
      <address>
        <city>Taipei</city>
        <zip>116</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</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>Bone Diseases, Metabolic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03245710
org study id: N201602096
nct id: NCT03245710
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study investigates the efficacy and mechanism of traditional Chinese medicine formula
      power product in the treatment of osteopenia in patients with pain. Half of participants will
      receive Chinese medicine formula power product, while the other half will receive a placebo.
Osteoporosis is a major public health problem, resulting in potentially pain and increasing
      risk of fracture. Treatment of osteoporosis consists of pharmacotherapy, lifestyle measures,
      dietary changes, mineral supplementation. Traditional Chinese medicine is a major component
      of health care in Taiwan and provides one treatment alternative for osteoporosis.

      Investigators investigate the efficacy and mechanism of traditional Chinese medicine formula
      powder product in the treatment of osteopenia patients with pain.This trial is a 12 weeks'
      randomized, placebo-controlled study. The study was approved by the Wan Fang hospital, and
      signed informed consent was obtained from each participant. 80 Osteopenia participants with
      pain were enrolled in this study. There were 80 participants aged 50 years or older included.
      Before random assignment to treatment, participants were at least moderate pain during 2
      weeks as identified by visual analogue scale (VAS) for more than 4. Bone mineral density
      (BMD) of all participants was -2.5 or below without diabetes, hyperthyroidism,
      hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis,
      bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever
      used steroids more than 3 week before assignment to treatment, Primary outcome measures were
      the change of VAS scale, Oswestry Disability Index and WHOQOL-BREF Taiwan at week 1 and 12.
      Secondary outcome was the genetic loci associated with a susceptibility to osteoprosis
      treated by traditional Chinese medicine formula powder product.

      Result : To provide evidence of the efficacy and mechanisms of ZBP powder product in the
      treatment of osteoporosis patients with pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain on the visual-analogue scales (VAS) for back and legs.
time frame: baseline and week 12
description: A VAS is a 100-mm-long horizontal line that is anchored by word descriptors at each end (no pain and worst pain possible). The patient selects the point on the line that best represents his or her perception of their pain level.
arm group label: Zhibai Dihuang powder
arm group type: Experimental
description: Arm: Experimental: Zhibai Dihuang Formula powder Zhibai Dihuang Formula powder: Traditional Chinese medicine formula powder product 5g by mouth, after meal, 3 times in one day for 12 weeks
arm group label: placebos
arm group type: Placebo Comparator
description: Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks
intervention type: Other
intervention name: Placebos
description: starch
arm group label: placebos
intervention type: Dietary Supplement
intervention name: Zhibai Dihuang powder
description: the Traditional Chinese Medicine Formula Powder Product
arm group label: Zhibai Dihuang powder
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Chung-Yu Huang, MD
role: Principal Investigator
affiliation: Taipei Municipal WanFang Hospital
last name: Chung-Yu Huang, MD
phone: +886-29307930
phone ext: 1710
email: hcy@tmu.edu.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Bone Diseases, Metabolic
sharing ipd: No