NCT02191280已完成2 期
The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 260
- 主要终点
- Changes from baseline of limb volume
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Antistax®, low dose
Experimental
干预措施: Antistax®, low dose (Drug)
Antistax®, high dose
Experimental
干预措施: Antistax®, high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline of limb volume
时间窗: Baseline, day 84
determined by water displacement
次要结局
- Measurement of ankle circumference(Baseline, days 42, 84 and 98)
- Changes of limb volume(Baseline, days 42 and 98)
- Measurement of calf circumference(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)
研究者
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