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

Primary Purpose

Ankle Fractures

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Helminthostachys zeylanica(L.)Hook
Starch
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ChangHua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Medication

Starch

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of American Orthopedic Foot and Ankle(AOFAS) Score
Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
Change of Ankle volume
figure-of-8 method

Secondary Outcome Measures

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
Fracture Healing
ankle radiography, bone callus formation and continuity of callus

Full Information

First Posted
January 4, 2019
Last Updated
August 5, 2021
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03805347
Brief Title
The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture
Official Title
The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
Keywords
Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Treatment group and Control group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blinded randomized
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication
Arm Type
Experimental
Arm Description
Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily
Arm Title
Starch
Arm Type
Placebo Comparator
Arm Description
Starch in capsule,1gm/time, 3 times daily
Intervention Type
Drug
Intervention Name(s)
Helminthostachys zeylanica(L.)Hook
Other Intervention Name(s)
Dao-Di-Wu-Gong
Intervention Description
Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
Intervention Type
Drug
Intervention Name(s)
Starch
Other Intervention Name(s)
Placebo
Intervention Description
Starch in capsule, 1gm/time, 3 times daily
Primary Outcome Measure Information:
Title
Change of American Orthopedic Foot and Ankle(AOFAS) Score
Description
Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
Time Frame
1st day of study, 10~14th days of study, 43th days of study
Title
Change of Ankle volume
Description
figure-of-8 method
Time Frame
1st day of study, 10~14th days of study, 43th days of study
Secondary Outcome Measure Information:
Title
Level of bone turnover marker
Description
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
Time Frame
1st day of study, 43th days of study
Title
Fracture Healing
Description
ankle radiography, bone callus formation and continuity of callus
Time Frame
1st day of study, 43th days of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Liang Hsieh, MD, PhD
Organizational Affiliation
Graduate Institute of Integrated Medicine,China Medical University,Taiwan.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lun Chien Lo, MD, PhD
Organizational Affiliation
School of Chinese Medicine,China Medical University,Taiwan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChangHua Christian Hospital
City
Changhua
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28169537
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28169537
Description
paper link

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

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