Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Thrombophlebitis Leg

Intervention / Treatment
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* Drug: Phlogenzym
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phlogenzym<br>Treatment with German licensed drug Phlogenzym (6 tablets/day) | Drug: Phlogenzym<br>* Bromelain / Trypsin / Rutoside<br>* Other names: Wobenzym plus;|
| Placebo Comparator: Placebo<br>Placebo equates Phlogenzym but without active ingredients | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombophlebitis