Antistax® in Patients With Chronic Venous Insufficiency

Inclusion Criteria:

• Male or female

• Between 25 and 75 years of age

• CVI I or CVI II (without expanded trophic disturbances)

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

Exclusion Criteria: Concomitant disease(s) exclusion criteria:

• Decompensated cardiac insufficiency

• Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renalinsufficiency, lymph edema, 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 (ALAT) > 3x upper limit of normal)

• Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- orhypocalcaemia, malignancies

• Anamnestic indications of diabetic microangiopathy or polyneuropathy

• Drug and/or alcohol abuse

• Severe climacteric complaints

• Immobility

• Avalvulia

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

• State after pulmonary embolism

• Recognized hypersensitivity to the trial drug ingredients

• Current florid venous ulcus

• Clinical indication for a necessary, specific phlebologic acute treatment, e.g.compressive treatment, phlebectomy, etc. Previous treatment(s) exclusion criteria:

• Treatment with venous drugs within the last 4 weeks

• Treatment with laxatives which affect fluid or electrolyte balance within the last 8days

• Changes in or unstable response to treatment with theophylline, diuretics, cardiacglycosides, ACE inhibitors or calcium antagonists within the last 8 days

• Changes in post-menopausal Hormone replacement within the last 2 months Concomitant treatment/non-drug therapy exclusion criteria:

• Other venous drugs apart from the trial medication

• Compression therapy

• Venous surgery at the leg(s)

• Extensive use (on more than a total of 6 days during the entire trial) of laxativeswhich affect fluid or electrolyte balance

• Major surgery requiring full anesthesia Other exclusion criteria:

• Previously studied under this protocol

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

• Patients who have visited a sauna or had other thermal applications in the previousday before any visit

• 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 judgment