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Completed

NCT Number: NCT03805347

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

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.

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Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ChangHua Christian Hospital

Changhua, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Helminthostachys zeylanica(L.)Hook

Drug

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

Other names: Dao-Di-Wu-Gong

Starch

Drug

Starch in capsule, 1gm/time, 3 times daily

Other names: Placebo

Primary outcomes

  1. Change of American Orthopedic Foot and Ankle(AOFAS) Score

    Time frame: 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

    Time frame: 1st day of study, 10~14th days of study, 43th days of study

    figure-of-8 method

Secondary outcomes

  1. Level of bone turnover marker

    Time frame: 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

    Time frame: 1st day of study, 43th days of study

    ankle radiography, bone callus formation and continuity of callus

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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