Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
| Son Doğrulandı: | 02/28/2018 |
| İlk təqdim: | 03/05/2018 |
| Təxmini qeydiyyat təqdim edildi: | 03/11/2018 |
| İlk Göndərmə: | 03/18/2018 |
| Son Yeniləmə Göndərildi: | 03/11/2018 |
| Son Yeniləmə Göndərildi: | 03/18/2018 |
| Həqiqi Təhsilin Başlama Tarixi: | 08/31/1996 |
| Təxmini İlkin Tamamlanma Tarixi: | 05/31/1997 |
| Təxmini İşin Tamamlanma Tarixi: | 05/31/1997 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Phlogenzym
Other: Placebo
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| 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 |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | 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 |
Nəticə
İlkin nəticə tədbirləri
1. Difference of pain at rest between values day 0 (baseline) and day 7 [Change day 0 until day 7]
2. Responders [day 14]
Digər nəticə tədbirləri
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]
