An interventional study of Yunnan Baiyao and Celecoxib 200mg in Distal Radius Fracture, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 58 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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Exclusion Criteria:
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
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
Drug: Celecoxib 200mg
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.
Also known as: celecoxib
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital