A Phase 3 interventional study of Phlogenzym and Placebo in Thrombophlebitis Leg, sponsored by Mucos Pharma GmbH & Co. KG. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by Mucos Pharma GmbH & Co. KG · Phase 3, Interventional, and Supportive care
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.
15 studies on the registry are indexed under Thrombophlebitis; 2 are open to participants now.
This study's enrollment of 100 is close to the median of 104 across 11 interventional studies indexed under Thrombophlebitis.
Browse Thrombophlebitis studies →Mucos Pharma GmbH & Co. KG is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with German licensed drug Phlogenzym (6 tablets/day)
Drug: Phlogenzym
Placebo equates Phlogenzym but without active ingredients
Other: Placebo
Bromelain / Trypsin / Rutoside
Also known as: Wobenzym plus
Difference of pain at rest between values day 0 (baseline) and 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: Change day 0 until day 7
Responders
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: day 14
Pain under Pressure
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
Symptoms
skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness
Time frame: 0, 4, 7, 14 days
Sum Score of Symptoms
Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)
Time frame: 0, 4, 7, 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Mucos Pharma GmbH & Co. KG