NCT02184234已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Number and intensity of serious and non-serious Adverse Events
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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.
研究组 & 干预措施
Antistax film coated tablets
Experimental
干预措施: Antistax film coated tablets (Drug)
结局指标
主要结局
Number and intensity of serious and non-serious Adverse Events
时间窗: up to 6 weeks
次要结局
- Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)(Baseline and after 6 weeks)
- Global tolerability assessment by the patient and investigator(after 42 days of treatment)
- Global assessment of efficacy by the patient and investigator(after 6 weeks)
- Vital sign parameters (blood pressure and pulse rate)(at screening and after 6 weeks)
研究者
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