NCT03470337

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mucos Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thrombophlebitis Leg

Interventions

Type	Name	Description
DRUG	Phlogenzym	Bromelain / Trypsin / Rutoside
OTHER	Placebo

Timeline

• Start date: 1996-09-01
• Primary completion: 1997-06-01
• Completion: 1997-06-01
• First posted: 2018-03-19
• Last updated: 2018-03-19

Locations

1 site across 1 country: Italy