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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
Starch in capsule, 1gm/time, 3 times daily
ChangHua Christian Hospital
Changhua, Taiwan
Change of American Orthopedic Foot and Ankle(AOFAS) Score
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
Change of Ankle volume
figure-of-8 method
Time frame: 1st day of study, 10~14th days of study, 43th days of study
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
Time frame: 1st day of study, 43th days of study
Fracture Healing
ankle radiography, bone callus formation and continuity of callus
Time frame: 1st day of study, 43th days of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.