drugset / Trial / NCT05765747
Effectiveness of Yunnan Baiyao in Improving Fracture Pain
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2023-12-31
- Completion
- 2024-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Celecoxib | Other / unclassified | 200 mg | — |
| Subject | Yunnan Baiyao | Traditional medicine (herbal / TCM) | — | — |
| Background | Baoxianzi | Unknown | — | — |
Indications
No indication recorded.