Antistax® in Patients With Chronic Venous Insufficiency

Study Overview
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Brief Summary
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Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II

Official Title
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The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Drug: Antistax®, low dose
* Drug: Antistax®, high dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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, renal insufficiency, 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- or hypocalcaemia, 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 8 days Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, 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 laxatives which 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 the present study Patients who have visited a sauna or had other thermal applications in the previous day before any visit Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only) Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial Patients in a bad general health state according to the investigator's judgment

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antistax®, low dose<br> | Drug: Antistax®, low dose<br> <br> |
| Experimental: Antistax®, high dose<br> | Drug: Antistax®, high dose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of limb volume | determined by water displacement | Baseline, day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of limb volume | determined by water displacement | Baseline, days 42 and 98 | 
| Measurement of calf circumference | in centimeters | Baseline, days 42, 84 and 98 | 
| Measurement of ankle circumference | in centimeters | Baseline, days 42, 84 and 98 | 
| Assessment of subjective symptoms on a visual analogue scale (VAS) |  | Baseline, days 42, 84 and 98 | 
| Assessment of global efficacy by patient on a 4-point verbal rating scale |  | days 42, 84 and 98 | 
| Assessment of global efficacy by investigator on a 4-point verbal rating scale |  | days 42, 84 and 98 | 
| Assessment of global tolerability by patient on a 4-point verbal rating scale |  | days 42, 84 and 98 | 
| Assessment of global tolerability by investigator on a 4-point verbal rating scale |  | days 42, 84 and 98 | 
| Number of patients with adverse events |  | up to 14 weeks |