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

MUCOS Pharma GmbH & Co. KG0 个研究点开始时间: 2012年11月23日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•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

•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

发起方