Acute Soft Tissue Injuries Caused by Falls, Strains, Sprains, Contusions, and Blunt Trauma
Conditions
Interventions
control group:Tongshu Capsule Simulator, TID, 3 capsules/time
Experimental group:Tongshu Capsules, TID, 3 capsules/time
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with acute closed soft tissue injuries caused by contusions, crush injuries, falls, abrasions, strains, sprains, or blunt trauma, accompanied by pain at the injury site. To ensure greater authority of the results, the trial primarily includes patients with the following common injury sites:; 1) Knee joint injuries: Patients with knee joint ligament or tendon injuries caused by contusions, crush injuries, falls, abrasions, strains, blunt trauma, and/or sprains. 2) Wrist injuries: Patients with wrist injuries caused by contusions, crush injuries, falls, abrasions, strains, blunt trauma, and/or sprains. 3) Calf injuries: Patients with calf muscle, ligament, or tendon injuries caused by contusions, crush injuries, falls, abrasions, strains, blunt trauma, and/or sprains. 2. Duration of pain within 72+/-5 hours; 3. Age between 18 and 70 years; 4. Pain VAS score >=4 and <=6; 5. Those who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with soft tissue injury sites accompanied by fractures, bone cracks, open wounds, or complete tears of muscles, tendons, ligaments, etc. 2. Combined with other inflammatory and painful diseases, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, villous nodular synovitis, joint trauma, septic arthritis, tuberculous arthritis, when the affected area is a joint area; 3. Patients with severe combined cardiovascular (e.g., myocardial infarction, stroke, etc.), hematologic (e.g., hemorrhagic tendency, coagulation dysfunction, etc.), hepatic, gastrointestinal, and renal disorders, and diabetes mellitus, which, in the judgment of the investigator, can affect the determination of the efficacy and safety of the test drug; 4. Psychiatric patients; 5. patients with severe pain in other parts of the body that may interfere with pain index assessment; 6. People for whom the VAS evaluation is not applicable, such as those with severe deficits in abstraction, visual and writing functions, and those who have been sedated; 7. Patients with systemic or localized infections or under treatment for infectious diseases at the time of screening; 8. Patients take short-acting NSAIDs or Chinese herbs with the efficacy of activating blood circulation and removing blood stasis, reducing swelling and relieving pain internally or externally within 12 hours before taking medication; use long-acting or extended-release NSAIDs within 3 days; and use corticosteroids or antibiotic therapy within one week; 9. Long-term use of other drugs that affect the efficacy and safety judgment of the test drug and those who take comprehensive treatment; 10. Pregnant or lactating women; 11. patients who have participated in other clinical trials within three months prior to screening; 12. Those with >=2 soft tissue injuries; 13. Those who, in the opinion of the investigator, should not be enrolled in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in VAS score of the target lesion at rest compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI and Ultrasound of the injured site;Swelling degree score;Days taken for pain relief (VAS score<4);Frequency and dosage of emergency medication use;SF-36 Quality of Life Score; | — |
Countries
China
Contacts
Public ContactYanlin Li
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed