<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/NCT03805347</url>
  </required_header>
  <id_info>
    <org_study_id>180917</org_study_id>
    <nct_id>NCT03805347</nct_id>
  </id_info>
  <brief_title>The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture</brief_title>
  <official_title>The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be&#xD;
      treated by surgical operation, local edema, pain and wound poor healing always is noted,&#xD;
      according to the investigator's knowledge, no good therapeutic methods to treat mention-above&#xD;
      symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has&#xD;
      anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often&#xD;
      uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin&#xD;
      component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and&#xD;
      ant-inflammation. Therefore, the purpose of the present study was to design a randomized,&#xD;
      double-blind, controlled study to evaluate functional recovery effect of Helminthostachys&#xD;
      zeylanica(L.)Hook after surgical operation in patients with ankle fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the purpose of the present study was to design a randomized, double-blind, controlled study&#xD;
      to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical&#xD;
      operation in patients with ankle fracture. The primary outcome measure was the scores change&#xD;
      of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape&#xD;
      (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism&#xD;
      in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2020</start_date>
  <completion_date type="Actual">January 11, 2021</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>Treatment group and Control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double-blinded randomized</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of American Orthopedic Foot and Ankle(AOFAS) Score</measure>
    <time_frame>1st day of study, 10~14th days of study, 43th days of study</time_frame>
    <description>Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Ankle volume</measure>
    <time_frame>1st day of study, 10~14th days of study, 43th days of study</time_frame>
    <description>figure-of-8 method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of bone turnover marker</measure>
    <time_frame>1st day of study, 43th days of study</time_frame>
    <description>Alkaline Phosphatase(ALP)normal range between 37 and 116 U/L; type 1 procollagen amino-terminal-propeptide (P1NP), normal range between 20-42 ng/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fracture Healing</measure>
    <time_frame>1st day of study, 43th days of study</time_frame>
    <description>ankle radiography, bone callus formation and continuity of callus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>Medication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Starch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Starch in capsule，1gm/time, 3 times daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Helminthostachys zeylanica(L.)Hook</intervention_name>
    <description>Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily</description>
    <arm_group_label>Medication</arm_group_label>
    <other_name>Dao-Di-Wu-Gong</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Starch</intervention_name>
    <description>Starch in capsule, 1gm/time, 3 times daily</description>
    <arm_group_label>Starch</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-75 year-old male or female with acute ankle fractures with surgical indication&#xD;
             (Joint line displacement &gt;2mm ; fracture dislocation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous skin disease, DM or peripheral vessel disease with local foot amputation.&#xD;
&#xD;
          -  Previous ankle surgery, old ankle fracture, or open fracture.&#xD;
&#xD;
          -  Liver or renal dysfunction, and cardiorespiratory failure.&#xD;
&#xD;
          -  Surgical infection after surgery.&#xD;
&#xD;
          -  Patient refuse or can't finish the treatment course&#xD;
&#xD;
          -  Patient with cancer&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  HIV positive.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching Liang Hsieh, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Graduate Institute of Integrated Medicine,China Medical University,Taiwan.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lun Chien Lo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Chinese Medicine,China Medical University,Taiwan.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ChangHua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28169537</url>
    <description>paper link</description>
  </link>
  <reference>
    <citation>Huang YL, Shen CC, Shen YC, Chiou WF, Chen CC. Anti-inflammatory and Antiosteoporosis Flavonoids from the Rhizomes of Helminthostachys zeylanica. J Nat Prod. 2017 Feb 24;80(2):246-253. doi: 10.1021/acs.jnatprod.5b01164. Epub 2017 Feb 7.</citation>
    <PMID>28169537</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ankle fracture</keyword>
  <keyword>Helminthostachys zeylanica(L.)Hook</keyword>
  <keyword>Clinical trials</keyword>
  <keyword>Functional recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Ankle Fractures</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/NCT03805347
org study id: 180917
nct id: NCT03805347
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be
      treated by surgical operation, local edema, pain and wound poor healing always is noted,
      according to the investigator's knowledge, no good therapeutic methods to treat mention-above
      symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has
      anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often
      uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin
      component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and
      ant-inflammation. Therefore, the purpose of the present study was to design a randomized,
      double-blind, controlled study to evaluate functional recovery effect of Helminthostachys
      zeylanica(L.)Hook after surgical operation in patients with ankle fracture.
the purpose of the present study was to design a randomized, double-blind, controlled study
      to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical
      operation in patients with ankle fracture. The primary outcome measure was the scores change
      of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape
      (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism
      in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Treatment group and Control group
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double-blinded randomized
measure: Change of American Orthopedic Foot and Ankle(AOFAS) Score
time frame: 1st day of study, 10~14th days of study, 43th days of study
description: Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
measure: Change of Ankle volume
time frame: 1st day of study, 10~14th days of study, 43th days of study
description: figure-of-8 method
measure: Level of bone turnover marker
time frame: 1st day of study, 43th days of study
description: Alkaline Phosphatase(ALP)normal range between 37 and 116 U/L; type 1 procollagen amino-terminal-propeptide (P1NP), normal range between 20-42 ng/L
measure: Fracture Healing
time frame: 1st day of study, 43th days of study
description: ankle radiography, bone callus formation and continuity of callus
arm group label: Medication
arm group type: Experimental
description: Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily
arm group label: Starch
arm group type: Placebo Comparator
description: Starch in capsule，1gm/time, 3 times daily
intervention type: Drug
intervention name: Helminthostachys zeylanica(L.)Hook
description: Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
arm group label: Medication
other name: Dao-Di-Wu-Gong
intervention type: Drug
intervention name: Starch
description: Starch in capsule, 1gm/time, 3 times daily
arm group label: Starch
other name: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ching Liang Hsieh, MD, PhD
role: Study Director
affiliation: Graduate Institute of Integrated Medicine,China Medical University,Taiwan.
last name: Lun Chien Lo, MD, PhD
role: Principal Investigator
affiliation: School of Chinese Medicine,China Medical University,Taiwan.
facility: 
country: Taiwan
url: https://www.ncbi.nlm.nih.gov/pubmed/28169537
description: paper link
citation: Huang YL, Shen CC, Shen YC, Chiou WF, Chen CC. Anti-inflammatory and Antiosteoporosis Flavonoids from the Rhizomes of Helminthostachys zeylanica. J Nat Prod. 2017 Feb 24;80(2):246-253. doi: 10.1021/acs.jnatprod.5b01164. Epub 2017 Feb 7.
PMID: 28169537
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Ankle Fractures
sharing ipd: No