Antistax® in Patients With Chronic Venous Insufficiency (NCT02191280) | Clinical Trial Compass
CompletedPhase 2
Antistax® in Patients With Chronic Venous Insufficiency
260 participantsStarted 1998-04
Plain-language summary
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
Who can participate
Age range25 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…