NCT01845558已完成4 期
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •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.
研究组 & 干预措施
Wobenzym® plus
Experimental
Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)
干预措施: Wobenzym® plus (Drug)
Placebo equates Wobenzym® plus but without active ingredients
Placebo Comparator
3x4 capsules/ day
干预措施: Placebo (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- blood pressure(immediately before, 24h, 48h, 72h)
- Maximal concentric strength (Nm) before and after the stress test(immediately before, 0h, 3h, 6h, 24h, 48h, 72h)
- Pressure induced pain(immediately before, 0h, 3h, 6h, 24h, 48h, 72h)
- Blood routine parameters(immediately before, 0h, 3h, 6h, 24h, 48h, 72h)
- Movement induced pain(immediately before, 0h, 3h, 6h, 24h, 48h, 72h post)
研究者
研究点 (1)
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