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A clinical study on the efficacy and safety of sodium aescinate tablets (Oukai) in the treatment of swelling caused by chronic venous insufficiency of the lower extremities

A multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of sodium aescinate tablets (Oukai) in the treatment of swelling caused by chronic venous insufficiency of the lower extremities

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070229
Enrollment
Unknown
Registered
2023-04-06
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Chronic venous insufficiency of the lower extremities

Interventions

Sponsors

Shanghai Pudong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 70 years old, no gender limitation; 2. Patients with CVI diagnosed by the researcher, and under conservative treatment with CEAP <= grade 3 or patients with pain,soreness or other clinical symptoms 1 month after operation; 3. Doppler ultrasound or CTV confirmed the presence of venous insufficiency of lower limbs; 4. Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients whose coagulation dysfunction will affect the outcome of this study according to the judgment of the investigator; 2. Patients with severe CVI, such as venous ulcer, CEAP >= grade 4 or patients with CEAP grade 4 or 5 without surgical indication; 3. Patients with acute inflammation; 4. CTV confirmed that patients with iliac vein compression, or PTS manifestated that patients need or can be performed surgical treatment or intracavitary recanalization; 5. Patients who are judged by the investigator to be unsuitable to participate in this clinical trial, such as cardiogenic edema, nephrogenic edema or hypoproteinemic edema; 6. Patients who received edema relief treatment within 2 weeks; 7. Patients with expected survival less than 1 year; 8. Known hypersensitivity or intolerance to the study drug components; 9. Participated in clinical trials of other drugs in the past three months or participated in other clinical trials during this trial.

Design outcomes

Primary

MeasureTime frame
Circumference of ankle;

Secondary

MeasureTime frame
VAS score for limb pain;venous clinical severity score, VCSS rating;

Countries

China

Contacts

Public ContactYu Bo

Shanghai Pudong Hospital

yubo120@hotmail.com+86 21 5802 2995

Outcome results

None listed

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