Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise (2012-005003-40)

Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial

The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.

Study Overview

• Status: Completed
• Conditions: Muscle Soreness; Muscle Injury; Exercise Induced Muscle Damage
• Intervention / Treatment: Other: Placebo; Drug: Wobenzym® plus

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Fürstenfeld Bruck, Germany, 82256
    • Sportschule FFb Puch GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
• Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
• Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
• Non smoker
• Men with strength training experience
• Age: 20-50 years
• BMI ≥20 kg/m2 and ≤ 32 kg/m2
• medium concentric strength ability (150-300 Nm)

Exclusion Criteria:

• Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture.
• No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial
• Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2.
• For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening
• Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance)
• Drug, alcohol and/or medication abuse
• Known HIV-infection
• Known acute or chronic hepatitis B and C infection
• Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
• Blood donation within 4 weeks prior to trial start (visit 1) or during trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wobenzym® plus; Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)	Drug: Wobenzym® plus
Placebo Comparator: Placebo equates Wobenzym® plus but without active ingredients; 3x4 capsules/ day	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test	Multidimensional approach for recovery and acute phase after eccentric stress test. Will be assessed at different time points before and after an excentric stress test and the reduction of these parameters under treatment will be calculated.	immediately before, 24h post, 48h post

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal concentric strength (Nm) before and after the stress test	Reduction of strength induced by the excentric stress test	immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Pressure induced pain	Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure	immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Blood routine parameters	Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters	immediately before, 0h, 3h, 6h, 24h, 48h, 72h
blood pressure	Blood pressure and heart rate as safety parameter	immediately before, 24h, 48h, 72h
Movement induced pain	Pain induced by a standardised movement and rated by the volunteer via VAS.	immediately before, 0h, 3h, 6h, 24h, 48h, 72h post

Collaborators and Investigators

• Sponsor: Mucos Pharma GmbH & Co. KG
• Investigators: Principal Investigator: Helmut Pabst, Dr. med, PWC GmbH

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Muscle soreness; Exercise induced muscle damage; Proteolytic enzymes; Muscle strength Dynamometer
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Wobenzym
• Other Study ID Numbers: BTS651/12; 2012-005003-40 (EudraCT Number)