Clinical trial NCT05765747: Effectiveness of Yunnan Baiyao in Improving Fracture Pain
Official title: A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of VAS pain scores from baseline after administration
timeFrame: within 14 weeks
Secondary outcomes:
measure: The time for fracture healing
timeFrame: within 14 weeks
measure: Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
timeFrame: within 14 weeks
measure: Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
timeFrame: within 14 weeks
measure: Changes from baseline in lumbar bone mineral density (BMD)
timeFrame: within 14 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Chunli Song, Pro.
role: PRINCIPAL_INVESTIGATOR
References: