Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise

Phase 4

Completed

• Conditions: Muscle Injury; Muscle Soreness; Exercise Induced Muscle Damage
• Interventions: Drug: Wobenzym® plus; Other: Placebo

• Registration Number: NCT01845558
• Lead Sponsor: Mucos Pharma GmbH & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wobenzym® plus	Wobenzym® plus	Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)
Placebo equates Wobenzym® plus but without active ingredients	Placebo	3x4 capsules/ day

Primary Outcome Measures

Name	Time	Method
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	immediately before, 24h post, 48h post	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sportschule FFb Puch GmbH; 🇩🇪 Fürstenfeld Bruck, Germany