Lower Extremity Varicose Veins
Conditions
Interventions
Treatment Group:Alvenor (Citrus Flavonoid Tablets). Dosage: 1 tablet twice daily. Administration starts on the first day postoperatively for a total of 14 days.2) Tongluo Huoxue Formula Administration
Control Group:Alvenor (Citrus Flavonoid Tablets). Each tablet contains 500 mg of citrus flavonoids including 450 mg of diosmin (90%) and 60 mg of hesperidin (10%). Manufactured by Servier (France) app
Sponsors
Putuo District Center Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Preoperative patients who meet the diagnostic criteria for lower extremity great saphenous varicose veins with CEAP classification ranging from C2 to C6 and have undergone combined endovenous laser closure and sclerotherapy in our department; 2) Patients who meet the TCM diagnostic criteria and syndrome types; 3) Patients aged 60 to 75 years regardless of gender; 4) Patients with hypertension whose blood pressure is stably controlled (<140/90 mmHg); 5) Patients with diabetes whose blood glucose is stably controlled (<11.1 mmol/L); 6) Patients who are informed about the study and willing to sign the informed consent form. Exclusion Criteria: If any of the above criteria is "no" the participant is ineligible for the trial.
Exclusion criteria
Exclusion criteria: 1) Patients with severe primary diseases of the cardiovascular cerebrovascular liver kidney and hematopoietic systems psychiatric disorders tumors or AIDS; those with serum creatinine or blood urea nitrogen > upper limit of normal value; ALT > upper limit of normal value; clinically significant arrhythmia; deep vein thrombosis indicated by preoperative lower extremity venography; lower extremity venous ulcers; coagulation dysfunction or autoimmune diseases; 2) Pregnant or lactating women individuals with allergic constitution or abnormal liver function; 3) Patients with severe infections or critical conditions; 4) Patients with diabetes mellitus and unstable blood glucose control (=11.1 mmol/L); 5) Patients with hypertension and unstable blood pressure control (=140/90 mmHg); 6) Individuals who do not meet the inclusion criteria fail to take medications as prescribed cannot have their efficacy evaluated or have incomplete data affecting the evaluation of efficacy or safety; 7) Individuals with other medical histories that in the judgment of the investigator reduce the possibility of enrollment or complicate enrollment such as frequent changes in work environment prone to loss to follow-up; 8) Study participants currently enrolled in other clinical drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation Criteria: Cure: Complete resolution of tendon-vein hard nodules with an efficacy index of 90%-100%. Marked Effect: Substantial subsidence of hard cords/nodules efficacy index 60%-90%. Effective: Partial resolution of hard cords/nodules efficacy index 30%-60%. Ineffective: Nodules increase in size ulcerate or show no change efficacy index <30%.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Referencing the Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS) a TCM clinical symptom score table was designed to comprehensively evaluate symptoms and signs of lower extremity redness swelling heat pain hard cords or nodular lesions before and after treatment and compare differences at pre-operation 3 days postoperatively 7 days postoperatively and 2 weeks postoperatively.; | — |
Countries
China
Contacts
Public Contactyi huang
Putuo District Center Hospital
Outcome results
None listed