The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
| Registry | NCT03805347 |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 45 (Actual) |
| Sponsor | Changhua Christian Hospital (Other) |
| Conditions | Ankle Fractures |
| Interventions | Helminthostachys zeylanica(L.)Hook, Starch (Drug) |
| Dates | start 2020-12-12, primary completion 2021-01-11, completion 2021-01-11, first posted 2019-01-15, last updated 2021-08-09 |
| Locations | 1 site in Taiwan |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Medication | Experimental | Drug: Helminthostachys zeylanica(L.)Hook | Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily |
| Starch | Placebo comparator | Drug: Starch | Starch in capsuleļ¼1gm/time, 3 times daily |
Sex: All, ages: 20 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| ChangHua Christian Hospital | Changhua | Taiwan |