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

Changhua Christian Medical Foundation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ankle Fractures

Treatments: Drug: Starch; Drug: Helminthostachys zeylanica(L.)Hook

Study type: Interventional

Funder types: Other

Identifiers

NCT03805347

180917

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Medication

Experimental group

Description:

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

Treatment:

Drug: Helminthostachys zeylanica(L.)Hook

Starch

Placebo Comparator group

Description:

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

Treatment:

Drug: Starch