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A Randomized, Blank Parallel Controlled, Open,Prospective,Multi-Center Clinical Study on the Treatment of Acute Closed Soft Tissue Injury of Unilateral Ankle and Foot with Yunnan Baiyao Aerosol

A Randomized, Blank Parallel Controlled, Open,Prospective,Multi-Center Clinical Study on the Treatment of Acute Closed Soft Tissue Injury of Unilateral Ankle and Foot with Yunnan Baiyao Aerosol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111008
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute closed soft tissue injury of the ankle and foot

Interventions

Experimental group:Conventional treatment combined with Yunnan Baiyao aerosol
Control group:Conventional treatment

Sponsors

Shanghai Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years; 2. Meet the Western medicine diagnostic criteria for acute closed soft tissue injury, and the injury is unilateral on the foot or ankle; 3. Disease duration <= 48 hours at screening; 4. Agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have fractures induced by pathological factors; 2. Patients who require plaster fixation, compression dressing, surgical treatment, etc., and cannot use the investigational drug; 3. Patients with blisters, ulcers, or suppuration on the injured skin; 4. Patients whose current foot and ankle pain and swelling are caused by other diseases, such as an acute episode of gout; 5. Patients with severe primary diseases and dysfunctions of the heart, brain, liver, kidney, hematopoietic system, endocrine system, etc.; 6. Patients known to be allergic to Yunnan Baiyao aerosol, alcohol, or similar substances, or with an allergic constitution (allergic to two or more drugs or foods); 7. Pregnant women; 8. Patients with mental illness, or poor compliance, who cannot cooperate with medication; 9. Other situations that the investigator considers inappropriate for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Foot and Ankle Ability Measure - Activities of Daily Living (FAAM-ADL);

Secondary

MeasureTime frame
Changes in the Functional Activities of the Ankle and Ankle (FAAM-ADL) scores from baseline;The change in swelling rate from baseline;Time taken for pain to subside to mild pain or less;The proportion of subjects whose pain became mild or less;Changes in swelling values relative to baseline;Change in VAS score for activity-related pain from baseline;Change in resting pain VAS score from baseline;

Countries

China

Contacts

Public ContactMa Xin

Shanghai Sixth People’s Hospital

maxin@sh163.net+86 21 52888007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026