Title
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
Phase
Phase 4Lead Sponsor
Mucos Pharma GmbH and CoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Muscle Injury Muscle Soreness Exercise Induced Muscle DamageIntervention/Treatment
wobenzyme ...Study Participants
69The 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.
Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)
3x4 capsules/ day
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.