Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan for the treatment of Colles' fracture.
详细描述
According to the definition of the World Health Organization, Taiwan officially entered the aged society in 2018. The population over the age of 65 exceeds 14% of the total population. Based on this, it is estimated that we will enter a super-aged society in 2026. Because the older the age, the higher the rate of bone loss, and the higher the risk of osteoporosis, the easier it is to fracture due to falls. The incidence of bone fracture is directly proportional to the aging population. Traditional Chinese Medicine(TCM) interventional fracture treatment has a long history and experience.
Many recent studies show that TCM is benefit to reduce risk of total hip replacement and has a positive influence on the prevention of osteoporotic fracture. In drug mechanism research, some Chinese herbal medicine has been proved to promote bone fracture healing . Although most of these researches have been confirmed in the laboratory, little information is available on true patients. In clinical we observe a lot of topical Chinese medicine been used after fracture, so the purpose of this thesis is to investigate the effective of topical Chinese herbal paste. This study may lead to build the usage of guideline after fracture.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People who are over 20 years old and have no lack of mental ability can understand the content of the experiment and are willing to participate in it.
- •Patients with Colles' fracture receive surgical fixation(ORIF).
排除标准
- •People are unable to cooperate with experiments and fill out questionnaires.
- •Patients have wounds on the back of their wrists.
- •Patients are allergic to traditional Chinese medicine for external applications or have used other traditional Chinese medicine for external applications.
- •Patients have cancer, stroke, and systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes, etc.
- •Pregnant woman.
研究组 & 干预措施
Ru-Yi-Jin-Huang-Saan
Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.
干预措施: Ru Yi Jin Huang Powder (Drug)
Placebo
Participants received a starch patch topically twice daily for 6 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6
时间窗: Baseline and Day 6
The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. 1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0. 2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Possible scores range from 0 (best score) to 100 (worst score). Change = (Day 6 score - Baseline score)
次要结局
- Change from Baseline with ultrasound at Day 6(Baseline and Day 6)
- Change from Baseline in C-reactive protein(CRP) at Day 6(Baseline and Day 6)
研究者
LienCheng Lin
Deputy Director of Department of Traditional Chinese Medicine
Changhua Christian Hospital