Chronic Venous Insufficiency
Conditions
Interventions
experimental group:Daphnetin Capsules
control group:Daphnetin Capsules Simulant
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 70 years old (including 18 and 70 years old), regardless of gender. (2) Meeting the diagnostic criteria for chronic venous insufficiency of the lower extremities. (3) CEAP classification diagnosis is at stages C2 - C4. (4) VCSS score >= 4 points. (5) The subject has been informed and gives consent, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Congenital venous/venolymphatic - venous malformations. (2) Deep vein thrombosis within 3 months. (3) Lymphedema: primary, post - traumatic, post - operative, post - radiotherapy, malignant. (4) Bilateral lower limb vein surgery within 3 months; (5) Unhealed lower - limb trauma, such as ulcers or infections in the affected limb. (6) Complicated by severe lower - limb ischemic diseases. (7) Having received chronic pain treatment within 14 days before enrollment. (8) Having used drugs with venoactive effects within 14 days before enrollment. Venoactive drugs include but are not limited to Diosmin tablets, Aescuven forte tablets, Citrus flavonoid tablets, Sodium Aescinate tablets, Xiaotuozhi - M, as well as traditional Chinese medicine preparations with similar efficacy. (9) Having regularly used compression therapy or mechanical devices to reduce edema within 14 days before enrollment. (10) Heart failure according to NYHA III and IV, congestive heart failure with peripheral edema. (11) Patients with severe liver and kidney function abnormalities (ALT > 3 times the upper limit of normal value; creatinine > 3 times the upper limit of normal value). (12) Refractory (uncontrollable) arterial hypertension (unable to achieve a treated systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg). (13) Patients with known uncorrectable bleeding or severe coagulation disorders. (14) Patients with malignant tumors. (15) Patients currently participating in another interventional or non - interventional study. (16) Alcohol or drug addiction. (17) Patients allergic to the study drugs or medical compression stockings. (18) Unable to cooperate with the study due to mental illness, cognitive or emotional disorders. (19) Pregnant or lactating women. (20) Subjects who, in the opinion of the investigator, are unsuitable for the study due to any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous Clinical Severity Score(VCSS);IL-6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical - Etiology - Anatomy - Pathophysiology (CEAP) Classification System;Visual Analogue Scale (VAS) for Pain;Chronic Venous Insufficiency Quality of Life Questionnaire;TNF-a; | — |
Countries
China
Contacts
Public ContactJu Shang
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed