Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency

Inclusion Criteria:

• Male or female

• 18 years of age or older

• CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease,e.g. pigmentation), according to the CEAP classification

• Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria: Concomitant diseases:

• Decompensated cardiac insufficiency

• Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency,renal insufficiency, lymphoedema, etc)

• Peripheral arterial disease (ankle/arm pressure index < 0.9)

• Current acute phlebitis or thrombosis

• Renal insufficiency (serum creatinine > 1.5 mg/dl)

• Liver disease (SGPT > 3x upper limit of normal)

• Other diseases: hyper- or hypocalcaemia, malignancies

• Anamnestic indications of diabetic microangiopathy or polyneuropathy

• Drug and/or alcohol abuse

• Severe climacteric complaints: changes in, or initiation with post-menopausal hormonereplacement therapy within the last 3 months

• Immobility

• Avalvulia

• Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus,Haemangiectasia hypertrophicans)

• State after pulmonary embolism

• Recognised hypersensitivity to the trial drug ingredients

• Current florid venous ulcus

• Clinical indication for a necessary, specific phlebologic acute treatment, e.g.compression treatment, phlebectomy, etc. Previous treatments:

• Patients who are on compression therapy and/or are wearing support stockings and whooptimally benefit from these measures

• Treatment with venous drugs within the last 2 weeks prior to the intake of studymedication

• Changes in or unstable response to treatment with theophylline, diuretics, cardiacglycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeksprior to the intake of study medication Concomitant treatment/non-drug therapy exclusion criteria:

• Other venous drugs apart from the trial medication

• Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry

• Extensive use of laxatives

• Major surgery requiring full anaesthesia Other exclusion criteria:

• Previously studied under this protocol

• Participation in another clinical trial within the previous 90 days or during thepresent study

• Patient is investigator, co-investigator, or study nurse in this study

• Pregnant or nursing women or inadequate birth control methods (this applies to femalesof childbearing potential only)

• Patients considered as mentally ill as well as unable to work or with limited workingability, or unable (or only partially able) to follow the spoken or writtenexplanations concerning the trial

• Patients in a bad general health state according to the investigator's judgement