Status:
COMPLETED
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
Lead Sponsor:
Mucos Pharma GmbH & Co. KG
Conditions:
Muscle Injury
Muscle Soreness
Eligibility:
MALE
20-50 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01845558
Start Date
February 1 2013
End Date
September 1 2014
Last Update
August 28 2015
Active Locations (1)
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1
Sportschule FFb Puch GmbH
Fürstenfeldbruck, Germany, 82256