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Study on the efficacy and safety of sodium aescinate tablets (Oukai) in the treatment of postoperative edema in patients with primary lower venous insufficiency

Study on the efficacy and safety of sodium aescinate tablets (Oukai) in the treatment of postoperative edema in patients with primary lower venous insufficiency

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041029
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Postoperative edema of primary venous insufficiency of lower extremity

Interventions

Treatment group:On the basis of conventional compression therapy with elastic stockings,sodium aescinate tablets were taken
Control group: conventional compression therapy with elastic stockings

Sponsors

The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, sex is not limited; 2. CVI patients with primary venous insufficiency of lower extremity with symptoms of C2-C5; 3. Ultrasound / CTV / MRV / venography confirmed the patency of deep vein of lower extremity; 4. The affected limb received CVI for the first time and has postoperative edema; 5. Understand and agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There were chronic venous reflux disorders in the affected limb, such as iliac vein compression, deep vein thrombosis syndrome, etc; 2. The limb was complicated with acute DVT or had a history of DVT in the past; 3. CVI operation was not performed; 4. CVI recurred after operation; 5. There were lower extremity edema caused by cardiogenic, hepatogenic and nephrogenic lymphatic reflux disorders; 6. Other anti edema drugs were used within 1 month; 7. According to the researcher, it may affect the patients' participation in the trial or affect the outcome of the trial, such as severe gravity function, liver function, renal insufficiency, etc; 8. Those who are not suitable to participate in the clinical trial, such as limb ulcer and infection; 9. Known to be allergic or intolerant to the components of the study drug; 10. Participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
The degree of swelling relief: the change of leg circumference on the 21st day of treatment compared with baseline was measured;

Secondary

MeasureTime frame
The degree of swelling relief: the change of leg circumference on the 10th?30th day of treatment compared with baseline was measured;The degree of swelling relief: the ankle circumference was measured on the 10th, 21st and 30th days after treatment compared with baseline;VCSS score;VAS score;AVVQ (Aberdeen Varicose Vein Questionnaire);Safety evaluation;

Countries

China

Contacts

Public ContactXinwu Lu

The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University

luxinwu@aliyun.com+86 21-23271699

Outcome results

None listed

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