NCT03805347

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

The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Changhua Christian Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
DRUG	Helminthostachys zeylanica(L.)Hook	Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
DRUG	Starch	Starch in capsule, 1gm/time, 3 times daily

Timeline

• Start date: 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 across 1 country: Taiwan