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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yunnan Baiyao | Experimental | 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. |
|
| celecoxib | Active Comparator | The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yunnan Baiyao | Drug | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan Wang, Ms. | Contact | 18251825313 | wh18324178960@163.com | |
| Chunli Song, Pro. | Contact | schl@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunli Song, Pro. | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| C530960 | yunnan baiyao |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Celecoxib 200mg | Drug | The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. |
|
|
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 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |