Clinical trial NCT03805347: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ankle Fractures
Keywords: Ankle fracture
Helminthostachys zeylanica(L.)Hook
Clinical trials
Functional recovery
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group and Control group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of American Orthopedic Foot and Ankle(AOFAS) Score
timeFrame: 1st day of study, 10~14th days of study, 43th days of study
measure: Change of Ankle volume
timeFrame: 1st day of study, 10~14th days of study, 43th days of study
Secondary outcomes:
measure: Level of bone turnover marker
timeFrame: 1st day of study, 43th days of study
measure: Fracture Healing
timeFrame: 1st day of study, 43th days of study
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: ChangHua Christian Hospital
Study officials:
affiliation: Graduate Institute of Integrated Medicine,China Medical University,Taiwan.
name: Ching Liang Hsieh, MD, PhD
role: STUDY_DIRECTOR
affiliation: School of Chinese Medicine,China Medical University,Taiwan.
name: Lun Chien Lo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.