Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Colles' Fracture

Intervention / Treatment
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* Drug: Ru Yi Jin Huang Powder
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ru-Yi-Jin-Huang-Saan<br>Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days. | Drug: Ru Yi Jin Huang Powder<br>* Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.<br>* Other names: golden patch;|
| Placebo Comparator: Placebo<br>Participants received a starch patch topically twice daily for 6 days. | Drug: Placebo<br>* Each patch contains 13g starch and 10c.c. water.<br>* Other names: starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6 | The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. 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. 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) | Baseline and Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in C-reactive protein(CRP) at 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) | Baseline and Day 6 | 
| Change from Baseline with ultrasound at 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) | Baseline and Day 6 |