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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805347
• Other study ID #: 180917
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 12, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: August 2021
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Taiwan	ChangHua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Huang YL, Shen CC, Shen YC, Chiou WF, Chen CC. Anti-inflammatory and Antiosteoporosis Flavonoids from the Rhizomes of Helminthostachys zeylanica. J Nat Prod. 2017 Feb 24;80(2):246-253. doi: 10.1021/acs.jnatprod.5b01164. Epub 2017 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of American Orthopedic Foot and Ankle(AOFAS) Score	Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points	1st day of study, 10~14th days of study, 43th days of study
Primary	Change of Ankle volume	figure-of-8 method	1st day of study, 10~14th days of study, 43th days of study
Secondary	Level of bone turnover marker	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	1st day of study, 43th days of study
Secondary	Fracture Healing	ankle radiography, bone callus formation and continuity of callus	1st day of study, 43th days of study

External Links

•   paper link