Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Study Overview
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Brief Summary
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This will be a randomized, controlled, non-inferiority designed clinical trial. 56 qualified subjects will be selected and allocated 1:1 to Yunnan Baiyao group and celecoxib group. Each subject will be treated for 2 weeks and observed for 12 weeks, which will be lasted for 14 weeks during the whole trial. Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks. The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.

Detailed Description
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his will be a randomized, controlled, non-inferiority designed clinical trial. 56 qualified subjects will be selected and allocated 1:1 to Yunnan Baiyao group and celecoxib group. Each subject will be treated for 2 weeks and observed for 12 weeks, which will be lasted for 14 weeks during the whole trial. Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks. The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.

Official Title
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A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Drug: Yunnan Baiyao
* Drug: Celecoxib 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of the subject is 20-70 years old; Patients with distal radius fractures (Colles fractures) ; Conservative treatment (closed reduction and fixation) after fracture; Willingness to participate in this study and sign the informed consent form (ICF). Exclusion Criteria: Pathological fractures such as multiple fractures and cancer; Patients with a history of severe chronic disease, such as hypertension, coronary heart disease, diabetes, tuberculosis, etc.; Patients with endocrine diseases unsuitable for inclusion or other related diseases affecting bone metabolism, such as thyroid diseases of clinical significance as hyperparathyroidism, parathyrometaplasia, Paget's disease, Cushing's syndrome, nephrotic rickets, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis insufficiency, etc.; Complicated with malignant tumor, mental illness and other diseases that doctors think may affect the test process; Currently using bone metabolism regulation drugs, such as teripartide, bisphosphonate, etc.; Had a history of chronic pain and used painkillers daily before enrollment; Nonsteroidal anti-inflammatory drugs, opioids, and physical therapy for pain relief within a week after fracture; pregnant and lactating women; Allergic to Yunnan Baiyao or any excipients and celecoxib, or suffering from contraindications or intolerance indicated by the test drug; continuous use of antibiotics; Patients with coagulation dysfunction, receiving anticoagulant therapy or taking antiplatelet aggregation drugs.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yunnan Baiyao<br>The Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks. | Drug: Yunnan Baiyao<br>* Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks.<br>|
| Active Comparator: celecoxib<br>The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. | Drug: Celecoxib 200mg<br>* The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.<br>* Other names: celecoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS pain scores from baseline after administration | Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain). | within 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for fracture healing | The degree of fracture healing was evaluated by observing 4 layers of cortex (anteroposterior and lateral) on X-ray films and mRUST score | within 14 weeks | 
| Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP) | Concentration determination of P1NP with unit of ng/mL | within 14 weeks | 
| Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX) | Concentration determination of β-CTX with unit of ng/mL | within 14 weeks | 
| Changes from baseline in lumbar bone mineral density (BMD) | Assessment of bone mineral density at the lumbar spine | within 14 weeks |