NCT05038410

Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment With Bromelain, Trypsin and Rutoside Versus Placebo in Subjects With OsTeoarthritis

Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment With Bromelain, Trypsin and Rutoside Versus Placebo in Subjects With OsTeoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mucos Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacodynamic profile of an oral enzyme treatment with Bromelain, Trypsin and Rutoside in subjects with osteoarthritis.

Detailed description

This study is a randomised, placebo controlled, two parallel arms, cross over, and multicentric trial in 40 male and female subjects suffering from osteoarthritis. While is it well established that Wobenzyme is safe and have proven efficacy in painful conditions, inflammation and osteoarthritis, little is known about its clear mechanism of action underlying its clinical efficacy. This study hypothesises that oral enzyme combination therapy with Wobenzyme will lead to systemic pharmacodynamic effects which will be documented by a holistic assessment of the inflammasome, innate immune system, cartilage turnover, systemic inflammatory markers, as well as potential cellular pathways.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Wobenzym®	Wobenzym®
OTHER	Placebo	Microcrystalline cellulose

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2021-09-09
• Last updated: 2024-11-22

Locations

5 sites across 1 country: Belgium