Acute closed soft tissue injury of the ankle
Conditions
Interventions
Experimental Group:Yunnan Baiyao Spray
Control Group:NA
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: 18 years old = age = 65 years old 2: The subject meets the diagnostic criteria for acute closed soft tissue injuries in Western medicine and has a unilateral ankle injury 3: The duration of the illness at the time of screening is =48 hours 4: The subject agrees to participate in this clinical trial and voluntarily signs the informed consent form
Exclusion criteria
Exclusion criteria: 1: Patients with fractures induced by pathological factors. 2: Patients who require treatments such as cast immobilization, compression wrapping, or surgery and are therefore unable to use the investigational drug. 3: Patients with blisters, open wounds, or abscesses on the injured skin. 4: Patients whose current ankle pain and swelling are caused by other diseases, such as acute gout. 5: Patients with severe primary diseases or functional impairments of the heart, brain, liver, kidneys, hematopoietic system, or endocrine system. 6: Patients with known allergies to Yunnan Baiyao spray, alcohol, or similar medications, or those with a history of allergies to two or more drugs or foods. 7: Pregnant women. 8: Patients with mental illness or poor compliance who are unable to cooperate with treatment. 9: Patients whom the investigator deems unsuitable for participation in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scores of the Functional Assessment of Ankle Mobility - Activities of Daily Living (FAAM-ADL) after medication compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in Ankle Function Assessment for Daily Living (FAAM-ADL) scores compared to baseline after 1 week, 2 weeks, and 3 weeks of medication.;The change in swelling rate compared to baseline after 1 week, 2 weeks, 3 weeks, and 4 weeks of drug administration.;The time for pain to transition to mild pain or below.;The proportion of subjects with pain reduced to mild or below after 1, 2, 3, and 4 weeks of treatment.;The changes in swelling values compared to baseline at week 1, week 2, week 3, and week 4 after drug administration.;The changes in VAS scores for activity-related pain compared to baseline at 1 week, 2 weeks, 3 weeks, and 4 weeks after treatment.;The changes in VAS scores for resting pain compared to baseline at 1 week after, 2 weeks after, 3 weeks after, and 4 weeks after medication.; | — |
Countries
China
Contacts
Public ContactMa Xin
Shanghai Sixth People's Hospital
Outcome results
None listed