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Effectiveness of Yunnan Baiyao in Improving Fracture Pain

Primary Purpose

Distal Radius Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yunnan Baiyao
Celecoxib 200mg
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.; 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.; 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.

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yunnan Baiyao

celecoxib

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
Concentration determination of P1NP with unit of ng/mL
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
Concentration determination of β-CTX with unit of ng/mL
Changes from baseline in lumbar bone mineral density (BMD)
Assessment of bone mineral density at the lumbar spine

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05765747
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yunnan Baiyao
Arm Type
Experimental
Arm Description
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.
Arm Title
celecoxib
Arm Type
Active Comparator
Arm Description
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Yunnan Baiyao
Intervention Description
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
Intervention Name(s)
Celecoxib 200mg
Other Intervention Name(s)
celecoxib
Intervention Description
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
Primary Outcome Measure Information:
Title
Change of VAS pain scores from baseline after administration
Description
Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain).
Time Frame
within 14 weeks
Secondary Outcome Measure Information:
Title
The time for fracture healing
Description
The degree of fracture healing was evaluated by observing 4 layers of cortex (anteroposterior and lateral) on X-ray films and mRUST score
Time Frame
within 14 weeks
Title
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
Description
Concentration determination of P1NP with unit of ng/mL
Time Frame
within 14 weeks
Title
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
Description
Concentration determination of β-CTX with unit of ng/mL
Time Frame
within 14 weeks
Title
Changes from baseline in lumbar bone mineral density (BMD)
Description
Assessment of bone mineral density at the lumbar spine
Time Frame
within 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.; 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.; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Wang, Ms.
Phone
18251825313
Email
wh18324178960@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunli Song, Pro.
Email
schl@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunli Song, Pro.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Wang, Ms.
Phone
18251825313
Ext
+86
Email
wh18324178960@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Yunnan Baiyao in Improving Fracture Pain

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