Venous Insufficiency
Conditions
Brief summary
To assess the efficacy and tolerability of Antistax film coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).
Interventions
DRUGRed vine leaf extract (AS 195)
Antistax film-coated tablet 360 mg
DRUGPlacebo
Placebo tablets identical to those containing Anstistax 360 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female 2. 18 years of age or older 3. CVI, Clinical Class 3 and Class 4a according to the CEAP classification 4. Presence of stable edema determined by a pretibial pit after 30 seconds pressure with the thumb documented by a photo 5. Stable and reproducible status of swelling documented by difference of less than 150g between screening and baseline as determined by water displacement method 6. Presence of moderate to severe varicoses (dilated, tortuous veins in the subcutaneous tissue with a diameter of more than 3mm 7. Intensity of leg pain at least 5 cm on the Visual Analogue Scale at baseline and presence of hyperpigmentation or eczema and presence of moderate to severe edema 8. Willing and able to give written informed consent prior to participation in the trial 9. Patients expected to be compliant (compliance with run-in medication greater than 80% as checked by drug count)
Exclusion criteria
1. Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients 2. Edema not due to venous disease of the legs(e.g. latent cardiac insufficiency, renal insufficiency, lymphoedema, etc) 3. Severe skin changes, e.g. lipodermatosclerosis 4. Current florid venous ulcer 5. Peripheral arterial disease (ankle/arm pressure index less than 0.9) 6. Untreated or insufficiently controlled hypertension 7. Current acute phlebitis of thrombosis with the last 3 months. Post-thrombotic syndrome, who do not currently receive an anticoagulation treatment can be included in the trial 8. Renal insufficiency 9. Liver disease; hepatic insufficiency 10. Hyper- or hypocalcemia 11. Malignancies 12. Anamnestic indications of diabetic microangiopathy or polyneuropathy 13. Drug and/or alcohol abuse 14. Severe climacteric complaints; changes in or initiation of post-menopausal hormone replacement therapy within the last 3 months 15. Immobility 16. Avalvulia 17. Klippel-Trénaunay-Weber-Syndrome 18. State after pulmonary embolism 19. Recognized hypersensitivity to the trial drug ingredients 20. Clinical indication for a specific phlebologic treatment, e.g. compression treatment phlebectomy, etc Previous Treatments: 1. Compression therapy and/or wearing of support stockings less than 2 weeks prior to the visit at baseline 2. Venous surgery or sclerotherapy with the last 3 months at the leg used for volumetry 3. Treatment with drugs affecting the veins less than 4 weeks prior to visit 1 4. Changes in or unstable response to treatment with theophylline, cardiac glycosides, ACE-inhibitors, calcium antagonists, or laxatives with the last 2 weeks prior to visit 1 Concomitant Treatment: 1. Compression therapy 2. Diuretics 3. Nitrates 4. Ergot alkaloids 5. All preparations which are used as compounds for venous therapy in CVI (e.g. vasoprotectives for antivaricose therapy, preparations with heparin, sclerosing agents, flavonoid-containing preparations, other phytopharmaceuticals 6. Other drugs active on blood vessels and circulation 7. Extensive use of laxatives 8. Anticipated changes in the intake of hormones, ie contraceptives 9. Scheduled major surgery requiring full anesthesia Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in limb volume determination at day 84 (water displacement method) | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs) pain in the legs) measured by Visual Analogue Scales at day 21,42 and 84 | 21, 42 and 84 days |
| Incidence of adverse events | 84 days |
| Global assessment of efficacy by the patient at day 84 | 84 days |
| Change from baseline in the calf circumference at day 21, 42 and 84 | 21, 42 and 84 days |
| Global assessment of efficacy by the investigator at day 84 | 84 days |
| Change from baseline in limb volume determination at day 21 and 42 (water displacement method) | 21 and 42 days |
| Vital signs (pulse rate, blood pressure) | 84 days |
| Number of patients with abnormal Serum Laboratory Parameters | 84 days |
| Global assessment of tolerability by the patient at day 84 | 84 days |
| Global assessment of tolerability by the investigator at day 84 | 84 days |
| Time to improvement in symptoms | 84 days |
Countries
Germany
Outcome results
None listed