Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Distal Radius Fracture Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05765747
• Other study ID #: M2022860
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2023
• Source: Peking University Third Hospital
• Contact: Huan Wang, Ms.
• Phone: 18251825313
• Email: wh18324178960[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• Yunnan Baiyao
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 200mg
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VAS pain scores from baseline after administration	Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain).	within 14 weeks
Secondary	The time for fracture healing	The degree of fracture healing was evaluated by observing 4 layers of cortex (anteroposterior and lateral) on X-ray films and mRUST score	within 14 weeks
Secondary	Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)	Concentration determination of P1NP with unit of ng/mL	within 14 weeks
Secondary	Changes from baseline in ß-C-terminaltelopeptide of type?collagen (ß-CTX)	Concentration determination of ß-CTX with unit of ng/mL	within 14 weeks
Secondary	Changes from baseline in lumbar bone mineral density (BMD)	Assessment of bone mineral density at the lumbar spine	within 14 weeks