NCT06872034

The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures

The Efficacy and Safety of Venostan (Horse Chestnut Seed Extract Tablets) in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures: A Multicenter, Open-Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Beijing Jishuitan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. General and disease-related data will be collected. All eligible patients must voluntarily sign an informed consent form after understanding and accepting the study. Successfully recruited participants will undergo internal fixation surgery at a scheduled time and then be randomly assigned to either the Venostan (horse chestnut seed extract tablet) group or the conventional treatment group. They will receive the corresponding treatments according to the study protocol. Follow-up assessments will include changes in ankle circumference, ankle range of motion, scale evaluation results, laboratory test results, and adverse events. The study aims to evaluate the effects of Venostasin in patients with ankle fractures undergoing internal fixation surgery, exploring its potential to promote postoperative reduction of ankle swelling, enhance early joint function recovery, and investigate its safety in postoperative fracture management.

Conditions

• Swelling/ Edema

Interventions

Type	Name	Description
DRUG	Venostasin (horse chestnut seed extract tablets)	Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days
OTHER	standard treatment	standard treatment

Timeline

• Start date: 2025-04-16
• Primary completion: 2026-01-12
• Completion: 2026-01-12
• First posted: 2025-03-12
• Last updated: 2025-07-16

Locations

1 site across 1 country: China