Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Peking University

Status: Not yet enrolling

Conditions: Distal Radius Fracture

Treatments: Drug: Celecoxib 200mg; Drug: Yunnan Baiyao

Study type: Interventional

Funder types: Other

Identifiers

NCT05765747

M2022860

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age of the subject is 20-70 years old;
2. Patients with distal radius fractures (Colles fractures) ;
3. Conservative treatment (closed reduction and fixation) after fracture;
4. Willingness to participate in this study and sign the informed consent form (ICF).

Exclusion criteria

1. Pathological fractures such as multiple fractures and cancer;
2. Patients with a history of severe chronic disease, such as hypertension, coronary heart disease, diabetes, tuberculosis, etc.;
3. Patients with endocrine diseases unsuitable for inclusion or other related diseases affecting bone metabolism, such as thyroid diseases of clinical significance as hyperparathyroidism, parathyrometaplasia, Paget's disease, Cushing's syndrome, nephrotic rickets, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis insufficiency, etc.;
4. Complicated with malignant tumor, mental illness and other diseases that doctors think may affect the test process;
5. Currently using bone metabolism regulation drugs, such as teripartide, bisphosphonate, etc.;
6. Had a history of chronic pain and used painkillers daily before enrollment; Nonsteroidal anti-inflammatory drugs, opioids, and physical therapy for pain relief within a week after fracture;
7. pregnant and lactating women;
8. Allergic to Yunnan Baiyao or any excipients and celecoxib, or suffering from contraindications or intolerance indicated by the test drug;
9. continuous use of antibiotics;
10. Patients with coagulation dysfunction, receiving anticoagulant therapy or taking antiplatelet aggregation drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

Yunnan Baiyao

Experimental group

Description:

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.

Treatment:

Drug: Yunnan Baiyao

celecoxib

Active Comparator group

Description:

The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.

Treatment:

Drug: Celecoxib 200mg