Trial | NCT03470337  Report issue

Title

Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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.
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.
Study Started
Sep 30
1996
Primary Completion
Jun 30
1997
Study Completion
Jun 30
1997
Last Update
Mar 19
2018

Drug Phlogenzym [anacaulase (NexoBrid), trypsin]

Bromelain / Trypsin / Rutoside

  • Other names: Wobenzym plus

Other Placebo

Phlogenzym Experimental

Treatment with German licensed drug Phlogenzym (6 tablets/day)

Placebo Placebo Comparator

Placebo equates Phlogenzym but without active ingredients

Criteria 

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
No Results Posted