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The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture

Sponsor
Changhua Christian Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03805347
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
30
Actual Duration (Days)
45.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Treatment group and Control groupTreatment group and Control group
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blinded randomized
Primary Purpose:
Treatment
Official Title:
The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
Actual Study Start Date :
Dec 12, 2020
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
Jan 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Medication

Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily

Drug: Helminthostachys zeylanica(L.)Hook
Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
Other Names:
  • Dao-Di-Wu-Gong

    		•
    Placebo Comparator: Starch

    Starch in capsuleļ¼Œ1gm/time, 3 times daily

    Drug: Starch
    Starch in capsule, 1gm/time, 3 times daily
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of American Orthopedic Foot and Ankle(AOFAS) Score [1st day of study, 10~14th days of study, 43th days of study]

      Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points

    2. Change of Ankle volume [1st day of study, 10~14th days of study, 43th days of study]

      figure-of-8 method

    Secondary Outcome Measures

    1. Level of bone turnover marker [1st day of study, 43th days of study]

      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

    2. Fracture Healing [1st day of study, 43th days of study]

      ankle radiography, bone callus formation and continuity of callus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 20-75 year-old male or female with acute ankle fractures with surgical indication (Joint line displacement >2mm ; fracture dislocation)
    Exclusion Criteria:

    • Previous skin disease, DM or peripheral vessel disease with local foot amputation.

    • Previous ankle surgery, old ankle fracture, or open fracture.

    • Liver or renal dysfunction, and cardiorespiratory failure.

    • Surgical infection after surgery.

    • Patient refuse or can't finish the treatment course

    • Patient with cancer

    • Pregnancy

    • HIV positive.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChangHua Christian Hospital Changhua Taiwan

    Sponsors and Collaborators

    • Changhua Christian Hospital

    Investigators

    • Study Director: Ching Liang Hsieh, MD, PhD, Graduate Institute of Integrated Medicine,China Medical University,Taiwan.
    • Principal Investigator: Lun Chien Lo, MD, PhD, School of Chinese Medicine,China Medical University,Taiwan.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Changhua Christian Hospital
    ClinicalTrials.gov Identifier:
    NCT03805347
    Other Study ID Numbers:
    • 180917
    First Posted:
    Jan 15, 2019
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Changhua Christian Hospital
    Ankle fracture
    Helminthostachys zeylanica(L.)Hook
    Clinical trials
    Functional recovery
    Additional relevant MeSH terms:
    Fractures, Bone
    Ankle Fractures

    Study Results

    No Results Posted as of Aug 9, 2021