Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mucos Pharma GmbH & Co. KG
Treatments:
Wobenzym
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.