Distal Radius FractureNCT05765747
Effectiveness of Yunnan Baiyao in Improving Fracture Pain
A study testing Yunnan Baiyao and Celecoxib 200mg in people with Distal Radius Fracture, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Yunnan Baiyao and Celecoxib 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Chunli Song, Pro. contact
China1 site
Peking University Third Hospital
Beijing
Huan Wang, Ms., 18251825313 ext. +86, wh18324178960@163.com
About this study
Official title: A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain
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.
Read the 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
- Being tested
- Yunnan Baiyao, Celecoxib 200mg
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yunnan BaiyaoDrug
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 200mgDrug
Also called celecoxib
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Yunnan Baiyao |
| celecoxib | Active comparator | The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. Receives: Drug: Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 14 weeks
Secondary outcomes (4)
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
Measured: within 14 weeks
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
Concentration determination of P1NP with unit of ng/mL
Measured: within 14 weeks
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
Concentration determination of β-CTX with unit of ng/mL
Measured: within 14 weeks
Changes from baseline in lumbar bone mineral density (BMD)
Assessment of bone mineral density at the lumbar spine
Measured: within 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunli Song, Pro., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765747
- Sponsor's protocol ID
- M2022860
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain
- ClinicalTrials.gov ID
- NCT05765747
- Acronym / sponsor ID
- M2022860
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yunnan Baiyao | Experimental | Drug: Yunnan BaiyaoThe 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 | Active comparator | Drug: Celecoxib 200mgThe celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yunnan BaiyaoYunnan 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 200mgAlso: celecoxibThe celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks. | Drug | celecoxib |
Primary outcome
Change of VAS pain scores from baseline after administration
Time frame: within 14 weeks
Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain).
4 secondary outcomes
The time for fracture healing
Time frame: within 14 weeks
Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)
Time frame: within 14 weeks
Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)
Time frame: within 14 weeks
Changes from baseline in lumbar bone mineral density (BMD)
Time frame: within 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunli Song, Pro. contact
Chunli Song, Pro. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yunnan Baiyao and Celecoxib 200mg in people with Distal Radius Fracture, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Wang, Ms. (18251825313, wh18324178960@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VAS pain scores from baseline after administration (time frame: within 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.