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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ankle Fractures

Intervention / Treatment
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* Drug: Helminthostachys zeylanica(L.)Hook
* Drug: Starch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group and Control group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication<br>Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily | Drug: Helminthostachys zeylanica(L.)Hook<br>* Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily<br>* Other names: Dao-Di-Wu-Gong;|
| Placebo Comparator: Starch<br>Starch in capsule，1gm/time, 3 times daily | Drug: Starch<br>* Starch in capsule, 1gm/time, 3 times daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of American Orthopedic Foot and Ankle(AOFAS) Score | Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points | 1st day of study, 10 14th days of study, 43th days of study | 
| Change of Ankle volume | figure-of-8 method | 1st day of study, 10 14th days of study, 43th days of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of bone turnover marker | 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 | 1st day of study, 43th days of study | 
| Fracture Healing | ankle radiography, bone callus formation and continuity of callus | 1st day of study, 43th days of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery