The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change of American Orthopedic Foot and Ankle(AOFAS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded randomized
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-75 year-old male or female with acute ankle fractures with surgical indication (Joint line displacement >2mm ; fracture dislocation)
排除标准
- •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.
研究组 & 干预措施
Medication
Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily
干预措施: Helminthostachys zeylanica(L.)Hook (Drug)
Starch
Starch in capsule，1gm/time, 3 times daily
干预措施: Starch (Drug)
结局指标
主要结局
Change of American Orthopedic Foot and Ankle(AOFAS) Score
时间窗: 1st day of study, 10~14th days of study, 43th days of study
Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
Change of Ankle volume
时间窗: 1st day of study, 10~14th days of study, 43th days of study
figure-of-8 method
次要结局
- Fracture Healing(1st day of study, 43th days of study)
- Level of bone turnover marker(1st day of study, 43th days of study)