Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

Study Overview
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Brief Summary
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Main objective: Safety and tolerability of Antistax® film coated tablets Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency

Official Title
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A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Drug: Antistax film coated tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema Male or female out-patients of any ethnic origin Age ranging from 25 to 75 years Exclusion Criteria: Known hypersensitivity to any ingredients of the study medication Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances Florid venous ulcers Arterial occlusive disease, irrespective of the severity Phlebitis or thrombophlebitis Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc. Evidence of diabetic micro-angiopathy or polyneuropathy in medical history Poor general health (based on the investigator's judgement) Addiction to alcohol abuse Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial Women of child-bearing age not using any reliable contraceptive methods Pregnant or lactating women Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antistax film coated tablets<br> | Drug: Antistax film coated tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and intensity of serious and non-serious Adverse Events |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global tolerability assessment by the patient and investigator |  | after 42 days of treatment | 
| Vital sign parameters (blood pressure and pulse rate) |  | at screening and after 6 weeks | 
| Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS) |  | Baseline and after 6 weeks | 
| Global assessment of efficacy by the patient and investigator |  | after 6 weeks |