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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2021-01-11

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.

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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.

Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment group and Control group

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double-blinded randomized

Study Groups

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Medication

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

Group Type EXPERIMENTAL

Helminthostachys zeylanica(L.)Hook

Intervention Type DRUG

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

Starch

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

Group Type PLACEBO_COMPARATOR

Starch

Intervention Type DRUG

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

Interventions

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Helminthostachys zeylanica(L.)Hook

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

Intervention Type DRUG

Starch

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

Intervention Type DRUG

Other Intervention Names

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Dao-Di-Wu-Gong Placebo

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No