NCT05765747

Effectiveness of Yunnan Baiyao in Improving Fracture Pain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
DRUG	Yunnan 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.
DRUG	Celecoxib 200mg	The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-31
• Completion: 2024-06-01
• First posted: 2023-03-13
• Last updated: 2023-03-13

Locations

1 site across 1 country: China