Effects of Wobenzym® plus in healthy, sportive people after muscular load - a randomized, two-stage, double-blind, placebo-controlled cross-over trial

Conditions: Healthy volunteersInfluence of the product on exercise induced muscle damage, noticable in temporal strength loss and muscle soreness. The indication is as defined in the SmPC: Swelling and inflammtion caused by injuries/ Trauma. in this case injury of the muscle.
Therapeutic area: Not possible to specify

Registration Number: EUCTR2012-005003-40-DE

Lead Sponsor: MUCOS Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

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, 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: 35-45 years
•BMI =20 kg/m2 and = 32 kg/m2
•medium concentric strength ability (180-300 Nm)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 musculo-skeletal 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
•Drug, alcohol and 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