Effectiveness of Yunnan Baiyao in Improving Fracture Pain

NCT ID: NCT05765747

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-01

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Yunnan Baiyao

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Celecoxib 200mg

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

Intervention Type: DRUG

Other Intervention Names

celecoxib

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunli Song, Pro.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Central Contacts

Huan Wang, Ms.

Role: CONTACT

wh18324178960@163.com

18251825313

Chunli Song, Pro.

Role: CONTACT

schl@bjmu.edu.cn

Facility Contacts

Huan Wang, Ms.

Role: primary

wh18324178960@163.com

18251825313 ext. +86

Other Identifiers

M2022860

Identifier Type: -

Identifier Source: org_study_id