Colles' Fracture
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan for the treatment of Colles' fracture.
Detailed description
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.
Interventions
DRUGPlacebo
Each patch contains 13g starch and 10c.c. water.
DRUGRu Yi Jin Huang Powder
Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients with Colles' fracture receive surgical fixation(ORIF).
Exclusion criteria
1. People are unable to cooperate with experiments and fill out questionnaires. 2. Patients have wounds on the back of their wrists. 3. Patients are allergic to traditional Chinese medicine for external applications or have used other traditional Chinese medicine for external applications. 4. Patients have cancer, stroke, and systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes, etc. 5. Pregnant woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in C-reactive protein(CRP) at Day 6 | Baseline and Day 6 | CRP is used primarily as an indicator of inflammation.The higher the value, the more severe the inflammation is. Change = (Day 6 score - Baseline score) |
| Change from Baseline with ultrasound at Day 6 | Baseline and Day 6 | ultrasound is used primarily as an indicator of swelling.The larger the value, the more swollen it is. Change = (Day 6 score - Baseline score) |
Countries
Taiwan
Contacts
Primary ContactLienCheng Lin, Master
Outcome results
None listed