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Completed

NCT Number: NCT01845558

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wobenzym® plus

Drug

Placebo

Other

Primary outcomes

  1. 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

    Time frame: immediately before, 24h post, 48h post

    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.

Secondary outcomes

  1. Maximal concentric strength (Nm) before and after the stress test

    Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h

    Reduction of strength induced by the excentric stress test

  2. Pressure induced pain

    Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h

    Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure

  3. Blood routine parameters

    Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h

    Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters

  4. blood pressure

    Time frame: immediately before, 24h, 48h, 72h

    Blood pressure and heart rate as safety parameter

  5. Movement induced pain

    Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h post

    Pain induced by a standardised movement and rated by the volunteer via VAS.

Sponsors and collaborators

Lead sponsor

Mucos Pharma GmbH & Co. KG

Industry

Registry information

Official study title

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

Acronym: 2012-005003-40

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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