Thrombophlebitis Leg
Conditions
Keywords
Thrombophlebitis
Brief 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.
Interventions
DRUGPhlogenzym
Bromelain / Trypsin / Rutoside
OTHERPlacebo
Sponsors
Mucos Pharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of pain at rest between values day 0 (baseline) and day 7 | 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. |
| Responders | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain under Pressure | 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) |
| Symptoms | 0, 4, 7, 14 days | skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness |
| Sum Score of Symptoms | 0, 4, 7, 14 days | Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness) |
Countries
Italy
Outcome results
None listed