Effectiveness of Yunnan Baiyao in Improving Fracture Pain

NCT05765747 | Unknown

• 1 other identifier: M2022860
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The time for fracture healing

  within 14 weeks

• Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)

  within 14 weeks

• Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)

  within 14 weeks

• Changes from baseline in lumbar bone mineral density (BMD)

  within 14 weeks

Study Arms (2)

Yunnan Baiyao

EXPERIMENTAL

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.

Drug: Yunnan Baiyao

celecoxib

ACTIVE COMPARATOR

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

Drug: Celecoxib 200mg

Interventions

Yunnan Baiyao 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.

Yunnan Baiyao

Celecoxib 200mg DRUG

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

Also known as: celecoxib

celecoxib

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age of the subject is 20-70 years old;
• Patients with distal radius fractures (Colles fractures) ;
• Conservative treatment (closed reduction and fixation) after fracture;
• Willingness to participate in this study and sign the informed consent form (ICF).

You may not qualify if:

• Pathological fractures such as multiple fractures and cancer;
• Patients with a history of severe chronic disease, such as hypertension, coronary heart disease, diabetes, tuberculosis, etc.;
• Complicated with malignant tumor, mental illness and other diseases that doctors think may affect the test process;
• Currently using bone metabolism regulation drugs, such as teripartide, bisphosphonate, etc.;
• 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;
• pregnant and lactating women;
• Allergic to Yunnan Baiyao or any excipients and celecoxib, or suffering from contraindications or intolerance indicated by the test drug;
• continuous use of antibiotics;
• Patients with coagulation dysfunction, receiving anticoagulant therapy or taking antiplatelet aggregation drugs.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

yunnan baiyao; Celecoxib

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chunli Song, Pro.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Wang, Ms.

CONTACT

18251825313; wh18324178960@163.com

Chunli Song, Pro.

CONTACT

schl@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)