Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 02/28/2018 |
| تم الإرسال لأول مرة: | 03/05/2018 |
| تم إرسال التسجيل المقدر: | 03/11/2018 |
| أول نشر: | 03/18/2018 |
| تم إرسال آخر تحديث: | 03/11/2018 |
| آخر تحديث تم نشره: | 03/18/2018 |
| تاريخ بدء الدراسة الفعلي: | 08/31/1996 |
| تاريخ الإنجاز الأساسي المقدر: | 05/31/1997 |
| التاريخ المتوقع لانتهاء الدراسة: | 05/31/1997 |
حالة أو مرض
التدخل / العلاج
Drug: Phlogenzym
Other: Placebo
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| 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 |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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 |
النتيجة
مقاييس النتائج الأولية
1. Difference of pain at rest between values day 0 (baseline) and day 7 [Change day 0 until day 7]
2. Responders [day 14]
تدابير النتائج الأخرى
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]
