Distal Radius Fracture
Conditions
Brief summary
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
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.
Interventions
DRUGYunnan Baiyao
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.
DRUGCelecoxib 200mg
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The age of the subject is 20-70 years old; 2. Patients with distal radius fractures (Colles fractures) ; 3. Conservative treatment (closed reduction and fixation) after fracture; 4. Willingness to participate in this study and sign the informed consent form (ICF).
Exclusion criteria
1. Pathological fractures such as multiple fractures and cancer; 2. Patients with a history of severe chronic disease, such as hypertension, coronary heart disease, diabetes, tuberculosis, etc.; 3. 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.; 4. Complicated with malignant tumor, mental illness and other diseases that doctors think may affect the test process; 5. Currently using bone metabolism regulation drugs, such as teripartide, bisphosphonate, etc.; 6. 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; 7. pregnant and lactating women; 8. Allergic to Yunnan Baiyao or any excipients and celecoxib, or suffering from contraindications or intolerance indicated by the test drug; 9. continuous use of antibiotics; 10. Patients with coagulation dysfunction, receiving anticoagulant therapy or taking antiplatelet aggregation drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of VAS pain scores from baseline after administration | within 14 weeks | Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time for fracture healing | within 14 weeks | The degree of fracture healing was evaluated by observing 4 layers of cortex (anteroposterior and lateral) on X-ray films and mRUST score |
| Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP) | within 14 weeks | Concentration determination of P1NP with unit of ng/mL |
| Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX) | within 14 weeks | Concentration determination of β-CTX with unit of ng/mL |
| Changes from baseline in lumbar bone mineral density (BMD) | within 14 weeks | Assessment of bone mineral density at the lumbar spine |
Countries
China
Contacts
Primary ContactHuan Wang, Ms.
Backup ContactChunli Song, Pro.
Outcome results
None listed