Ankle Fractures
Conditions
Keywords
Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery
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.
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.
Interventions
DRUGHelminthostachys zeylanica(L.)Hook
Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
DRUGStarch
Starch in capsule, 1gm/time, 3 times daily
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded randomized
Intervention model description
Treatment group and Control group
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change of Ankle volume | 1st day of study, 10~14th days of study, 43th days of study | figure-of-8 method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fracture Healing | 1st day of study, 43th days of study | ankle radiography, bone callus formation and continuity of callus |
Countries
Taiwan
Outcome results
None listed