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

Mucos Pharma

Status and phase

Completed

Phase 4

Conditions

Muscle Injury

Exercise Induced Muscle Damage

Muscle Soreness

Treatments

Other: Placebo

Drug: Wobenzym® plus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01845558

BTS651/12

2012-005003-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.