Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 02/28/2018 |
| Прво доставено: | 03/05/2018 |
| Поднесено е проценето запишување: | 03/11/2018 |
| Прво објавено: | 03/18/2018 |
| Последното ажурирање е доставено: | 03/11/2018 |
| Последно ажурирање објавено: | 03/18/2018 |
| Крај на датумот на започнување на студијата: | 08/31/1996 |
| Проценет датум на примарно завршување: | 05/31/1997 |
| Проценет датум на завршување на студијата: | 05/31/1997 |
Состојба или болест
Интервенција / третман
Drug: Phlogenzym
Other: Placebo
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| 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 |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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 |
Исход
Мерки на примарниот исход
1. Difference of pain at rest between values day 0 (baseline) and day 7 [Change day 0 until day 7]
2. Responders [day 14]
Други мерки на исход
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]
