Efficacy and Safety of Horse Chestnut Seed Extract Combined with Micronized Purified Flavonoid Fraction in the Treatment of Chronic Venous Disease: A Multicenter, Randomized, Controlled Study

Efficacy and Safety of Horse Chestnut Seed Extract Combined with Micronized Purified Flavonoid Fraction in the Treatment of Chronic Venous Disease: A Multicenter, Randomized, Controlled Study - Horse Chestnut Seed Extract Combined with Micronized Purified Flavonoid Fraction in the Treatment of Chronic Venous Disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122968

Enrollment

Unknown

Registered

2026-04-20

Start date

2025-07-10

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Chronic Venous Disease

Interventions

Experiment Group:MPFF combined with HCSE, Micronized Diosmin Tablet 450 mg bid plus Horse Chestnut Seed Extract Tablet 800mg bid for consecutive 6 weeks

Control Group:MPFF: Micronized Diosmin Tablet 450 mg bid only for consecutive 6 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years (18 = 4.0 mm during the initial evaluation; 6. Understand the procedures and methods of the trial, willing to strictly adhere to the clinical research protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or intolerance to the studied drug components; 2. Women who are pregnant, planning pregnancy during the trial, or in the breastfeeding period; 3. Opting for pressure therapy; 4. Opting for surgical treatment of CVD or having undergone CVD surgery within the past 3 months; 5. CVD caused by secondary (post-thrombotic syndrome) or congenital factors (vascular malformations, K-T syndrome); 6. Presence of lower limb deep vein thrombosis; 7. Presence of soft tissue infection in the affected limb; 8. Presence of lymphedema in the affected limb; 9. Presence of chronic gastrointestinal symptoms or gastrointestinal diseases; 10. Presence of severe (decompensated) heart, lung, liver, kidney, or blood disorders; 11. Presence of uncontrolled diabetes or diabetic complications; 12. Presence of lower limb arterial disease; 13. Heavy smoking and drinking habits (smoking >= 10 cigarettes per day on average, alcohol consumption >= 50 mL of alcohol per day on average); 14. Currently participating in other drug or device clinical trials; 15. Presence of other conditions that, in the investigator's judgment, do not meet the study requirements.

Design outcomes

Primary

Measure	Time frame
Global Venous Symptom Score;Time to relieve;	—

Secondary

Measure	Time frame
CIVIQ-14 QoL;Ankel circumference;Calf circumference;	—

Countries

China

Contacts

Public ContactMao Zhang

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

zbysz1118@126.com+86 191 5027 6387

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026