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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
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.
Peking University Third Hospital
Beijing, China
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).
Time frame: within 14 weeks
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
Time frame: within 14 weeks
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
Concentration determination of P1NP with unit of ng/mL
Time frame: within 14 weeks
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
Concentration determination of β-CTX with unit of ng/mL
Time frame: within 14 weeks
Changes from baseline in lumbar bone mineral density (BMD)
Assessment of bone mineral density at the lumbar spine
Time frame: within 14 weeks
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