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

Phase 1

Completed

• Conditions: Ankle Fractures
• Interventions: Drug: Helminthostachys zeylanica(L.)Hook; Drug: Starch

• Registration Number: NCT03805347
• Lead Sponsor: Changhua Christian Hospital

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.

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Study Start: 2020-12-12
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication	Helminthostachys zeylanica(L.)Hook	Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily
Starch	Starch	Starch in capsule，1gm/time, 3 times daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fracture Healing	1st day of study, 43th days of study	ankle radiography, bone callus formation and continuity of callus
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

Trial Locations

Locations (1)

ChangHua Christian Hospital; 🇨🇳 Changhua, Taiwan