Study on the efficacy and safety of sodium aescinate tablets (Oukai) in the treatment of postoperative soft tissue edema in patients with limbs closed fracture

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061992

Enrollment

Unknown

Registered

2022-07-16

Start date

2022-08-15

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

postoperative soft tissue edema in patients with limbs closed fracture

Interventions

Experimental group:On the basis of routine treatment, sodium aescinate tablets were taken orally

Control group:Routine treatment

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients aged >= 18 years old and <= 60 years old, regardless of gender; 2. Patients with closed fractures of the long tubular bones of the limbs who need surgical treatment; 3. Patients whose fracture sites are fixed with titanium alloys, biomaterials and other feasible MRI scans; 4. Those who understand and agree to participate in this research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who used corticosteroid drugs 5 days before the start of this clinical study; 2. Those who are using other diuretics or anti-edema treatments; 3. Those who received long-acting non-steroidal anti-inflammatory drugs 3 days before the start of this clinical study; 4. Serious associated injuries, such as organ injury, craniocerebral injury, severe vascular injury, etc.; 5. Severe cardiovascular diseases, such as severe cardiac insufficiency, second or third degree atrioventricular block, etc.; 6. Endocrine diseases that may affect this test, such as type II diabetes, hyperthyroidism, etc.; 7. Nervous system diseases that may affect this test, such as epilepsy, Parkinson's disease, etc.; 8. Severe hepatic insufficiency: ALT and AST exceeding 1.5 times the upper limit of normal value; 9. Severe renal insufficiency: defined as creatinine greater than 1.5 times the upper limit of normal value; 10. Autoimmune diseases, such as systemic lupus erythematosus, etc.; 11. History of major surgery, including splenectomy, etc.; 12. Combined severe infection.

Design outcomes

Primary

Measure	Time frame
Tissue edema score;	—

Secondary

Measure	Time frame
Cross sectional area of soft tissue edema;Circumference of edema site;Visual analogue scale score ;	—

Countries

China

Contacts

Public ContactDai Min

The First Affiliated Hospital of Nanchang University

daimin@medmail.com.cn+86 13767181616

Outcome results

None listed

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