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A multicenter clinical study on Yunnan Baiyao Capsules for the treatment of limb swelling around ankle fractures

A multicenter clinical study on Yunnan Baiyao Capsules for the treatment of limb swelling around ankle fractures

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103255
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Periankle fracture

Interventions

Treatment group:Yunnan Baiyao Capsules, 4 times a day, 2 capsules each time
placebo group:Placebo 4 times a day, 2 pills each time

Sponsors

Shenzhen University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: For ankle fractures that meet the diagnostic criteria and are diagnosed as ankle periarticular fractures within 7 days, the surgical approach is open reduction and internal fixation; 2: Swelling degree greater than or equal to grade II (on the first day after surgery); 3: Voluntarily sign an informed consent form before the start of the study and record the informed consent process in relevant documents such as the original medical records. 4: Between the ages of 18 and 80

Exclusion criteria

Exclusion criteria: 1: Patients with open fractures, old fractures, and multiple fractures (1 or more); 2: Patients with fractures induced by rational factors due to illness; 3: Patients with combined vascular, nerve, and visceral injuries; 4: Patients with severe malnutrition (BMI<16 kg/m ²); 5: Patients with diseases such as gout/rheumatism/arthritis/synovitis that are prone to ankle pain and swelling; 6: Known to be allergic to Yunnan Baiyao capsules or similar drugs, or have an allergic constitution (allergic to two or more drugs or foods); 7: Patients treated with drugs that promote blood circulation, remove blood stasis, reduce swelling, and relieve pain within 72 hours before enrollment (excluding perioperative analgesics) 8: Patients who have suffered from acute myocardial infarction, cerebrovascular accident, severe trauma, or major surgery within 6 months prior to enrollment; 9: Patients with liver function (ALT, AST) higher than 1.5 times the upper limit of normal values and serum creatinine (SCr) higher than the upper limit of normal values; 10: Patients with severe gastrointestinal diseases, such as ulcers; 11: Serious systemic diseases, such as malignant tumors, serious metabolic diseases (such as uncontrolled diabetes), serious hematopoietic system diseases (such as hemolytic anemia), etc; 12: Suffering from other diseases that may affect the efficacy evaluation, such as severe varicose veins; 13: Patients with mental illness or poor compliance who cannot cooperate with medication; 14: Long term use of glucocorticoids; 15: Patients known to have a history of alcohol addiction or drug abuse; 16: Women who are breastfeeding or pregnant, women of childbearing age, or male patients whose partners do not agree to take effective contraceptive measures during the study period; 17: Individuals who have participated in and used other drugs/devices in clinical trials within the past 3 months prior to enrollment; 18: Other patients who are deemed unsuitable by the researchers to participate in this study.

Design outcomes

Primary

MeasureTime frame
Swelling measurement on postoperative day 7;

Secondary

MeasureTime frame
Swelling rate;Range of Motion, ROM;The use of painkillers;Incidence of complications;

Countries

China

Contacts

Public ContactBaoguo Jiang

Shenzhen University General Hospital

jiangbaoguo@vip.sina.com+86 136 0122 8528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026