Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Not Applicable

Not yet recruiting

• Conditions: Distal Radius Fracture
• Interventions: Drug: Yunnan Baiyao; Drug: Celecoxib 200mg

• Registration Number: NCT05765747
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Study Start: 2023-04-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of VAS pain scores from baseline after administration	within 14 weeks	Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain).

Secondary Outcome Measures

Name	Time	Method
The time for fracture healing	within 14 weeks	The degree of fracture healing was evaluated by observing 4 layers of cortex (anteroposterior and lateral) on X-ray films and mRUST score
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)	within 14 weeks	Concentration determination of P1NP with unit of ng/mL
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)	within 14 weeks	Concentration determination of β-CTX with unit of ng/mL
Changes from baseline in lumbar bone mineral density (BMD)	within 14 weeks	Assessment of bone mineral density at the lumbar spine

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China