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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Fractures
• Intervention / Treatment: Drug: Helminthostachys zeylanica(L.)Hook; Drug: Starch

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan
    • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication; Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily	Drug: Helminthostachys zeylanica(L.)Hook; Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily; Other Names: Dao-Di-Wu-Gong
Placebo Comparator: Starch; Starch in capsule，1gm/time, 3 times daily	Drug: Starch; Starch in capsule, 1gm/time, 3 times daily; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change of Ankle volume	figure-of-8 method	1st day of study, 10~14th days of study, 43th days of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fracture Healing	ankle radiography, bone callus formation and continuity of callus	1st day of study, 43th days of study

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Investigators: Study Director: Ching Liang Hsieh, MD, PhD, Graduate Institute of Integrated Medicine,China Medical University,Taiwan.; Principal Investigator: Lun Chien Lo, MD, PhD, School of Chinese Medicine,China Medical University,Taiwan.

Publications and helpful links

General Publications

• 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.

Helpful Links

• paper link

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Functional recovery; Clinical trials; Ankle fracture; Helminthostachys zeylanica(L.)Hook
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 180917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No