Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance - Randomised Double-blind Study Phase III With Parallel Groups vs. Placebo According to the Guidelines of Good Clinical Practice (GCP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference of pain at rest between values day 0 (baseline) and day 7
研究概览
简要总结
Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.
详细描述
Enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. There, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. Similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.Proteases have also been indicated to show a certain improvement of the fluidity of the blood. An additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis);
- •age ~ 18 years;
- •acute thrombophlebitis in the lower leg
- •moderate to severe pain as monitored on a visual analog scale (VAS, value ≥ 3 cm)
- •pain under pressure
- •presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness.
排除标准
- •known deep phlebothrombosis
- •flourishing ulcus cruris
- •arterial occlusive disease
- •peripheral neuropathy
- •malignant disease
- •concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics;
- •known intolerance against the active ог the inactive ingredients of the study medication (especially lactose);
- •pregnancy
- •lactation,
- •known alcohol or drug abuse
- •participation in another clinical study
研究组 & 干预措施
Phlogenzym
Treatment with German licensed drug Phlogenzym (6 tablets/day)
干预措施: Phlogenzym (Drug)
Placebo
Placebo equates Phlogenzym but without active ingredients
干预措施: Placebo (Other)
结局指标
主要结局
Difference of pain at rest between values day 0 (baseline) and day 7
时间窗: Change day 0 until day 7
Patients were asked to evaluate resting pain on day 0 (baseline) as well as day 7 on a 10-cm VAS (Visual Analogue Scale), with the left end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain". The distance from the left end was recorded.
Responders
时间窗: day 14
Number of responders (pain value smaller or equal to 1 cm on visual analogue scale for pain (VAS, eft end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain") on day 14
次要结局
未报告次要终点