Dr. Baumueller
Fano, 61032, Italy
NCT Number: NCT03470337
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Fano, 61032, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bromelain / Trypsin / Rutoside
Other names: Wobenzym plus
Time frame: Change day 0 until day 7
Patients were asked to evaluate resting pain on day 0 (baseline) as well as day 7 on a 10-cm VAS (Visual Analogue Scale), with the left end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain". The distance from the left end was recorded.
Time frame: day 14
Number of responders (pain value smaller or equal to 1 cm on visual analogue scale for pain (VAS, eft end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain") on day 14
Time frame: 0, 4, 7, 14 days
Meyer's pressure points at the lateral side of the tibia and Krieger's pressure point in the popliteal space, 4-point rating scale ranging from 0 (no pain) to 3 (severe pain)
Time frame: 0, 4, 7, 14 days
skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness
Time frame: 0, 4, 7, 14 days
Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)
Mucos Pharma GmbH & Co. KG
Industry
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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