Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    wobenzyme ...
  • Study Participants

    69
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.
Study Started
Feb 28
2013
Primary Completion
Sep 30
2014
Study Completion
Sep 30
2014
Last Update
Aug 28
2015
Estimate

Drug Wobenzym® plus

Other Placebo

Wobenzym® plus Experimental

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

Placebo equates Wobenzym® plus but without active ingredients Placebo Comparator

3x4 capsules/ day

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.
No Results Posted