ClinicalTrials.Veeva

Menu

Effectiveness of Yunnan Baiyao in Improving Fracture Pain

P

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

Trial contacts and locations

1

Loading...

Central trial contact

Chunli Song, Pro.; Huan Wang, Ms.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems