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

Muscle Soreness Clinical Trial

— 2012-005003-40  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845558
• Other study ID #: BTS651/12
• Secondary ID: 2012-005003-40
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2013
• Last updated: August 27, 2015
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Mucos Pharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Induced Muscle Damage
• Muscle Injury
• Muscle Soreness
• Myalgia

Intervention

Drug:
• Wobenzym® plus

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Sportschule FFb Puch GmbH	Fürstenfeld Bruck

Sponsors (1)

Lead Sponsor	Collaborator
Mucos Pharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Blood routine parameters	Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters	immediately before, 0h, 3h, 6h, 24h, 48h, 72h	Yes
Secondary	blood pressure	Blood pressure and heart rate as safety parameter	immediately before, 24h, 48h, 72h	Yes
Secondary	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	No