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

NCT ID: NCT01845558

Last Updated: 2015-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-09-30

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.

Conditions

Muscle Injury; Muscle Soreness; Exercise Induced Muscle Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Wobenzym® plus

Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)

Group Type: EXPERIMENTAL

Wobenzym® plus

Intervention Type: DRUG

Placebo equates Wobenzym® plus but without active ingredients

3x4 capsules/ day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Wobenzym® plus

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mucos Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Pabst, Dr. med

Role: PRINCIPAL_INVESTIGATOR

PWC GmbH

Locations

Sportschule FFb Puch GmbH

Fürstenfeldbruck, , Germany

Countries

Germany

Other Identifiers

2012-005003-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BTS651/12

Identifier Type: -

Identifier Source: org_study_id