NCT03805347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

January 4, 2019

Last Update Submit

August 5, 2021

Conditions

Ankle Fractures

Keywords

Ankle fractureHelminthostachys zeylanica(L.)HookClinical trialsFunctional recovery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Level of bone turnover marker

    1st day of study, 43th days of study

  • Fracture Healing

    1st day of study, 43th days of study

Study Arms (2)

Medication

EXPERIMENTAL

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

Drug: Helminthostachys zeylanica(L.)Hook

Starch

PLACEBO COMPARATOR

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

Drug: Starch

Interventions

Helminthostachys zeylanica(L.)HookDRUG

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

Also known as: Dao-Di-Wu-Gong
Medication
StarchDRUG

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

Also known as: Placebo
Starch

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year-old male or female with acute ankle fractures with surgical indication (Joint line displacement \>2mm ; fracture dislocation)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangHua Christian Hospital

Changhua, Taiwan

Location

Related 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.

    PMID: 28169537BACKGROUND

Related Links

MeSH Terms

Conditions

Ankle Fractures

Interventions

Starch

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Ching Liang Hsieh, MD, PhD

    Graduate Institute of Integrated Medicine,China Medical University,Taiwan.

    STUDY DIRECTOR

  • Lun Chien Lo, MD, PhD

    School of Chinese Medicine,China Medical University,Taiwan.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double-blinded randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment group and Control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 15, 2019

Study Start

December 12, 2020

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)