Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
关键词
抽象
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.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 03/05/2018 |
| 提交的预估入学人数: | 03/11/2018 |
| 首次发布: | 03/18/2018 |
| 上次提交的更新: | 03/11/2018 |
| 最近更新发布: | 03/18/2018 |
| 实际学习开始日期: | 08/31/1996 |
| 预计主要完成日期: | 05/31/1997 |
| 预计完成日期: | 05/31/1997 |
状况或疾病
干预/治疗
Drug: Phlogenzym
Other: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Phlogenzym Treatment with German licensed drug Phlogenzym (6 tablets/day) | Drug: Phlogenzym Bromelain / Trypsin / Rutoside |
| Placebo Comparator: Placebo Placebo equates Phlogenzym but without active ingredients | Other: Placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
结果
主要结果指标
1. Difference of pain at rest between values day 0 (baseline) and day 7 [Change day 0 until day 7]
2. Responders [day 14]
其他成果措施
1. Pain under Pressure [0, 4, 7, 14 days]
2. Symptoms [0, 4, 7, 14 days]
3. Sum Score of Symptoms [0, 4, 7, 14 days]
