Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
研究概览
简要总结
To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and inflammatory immune response over a period of 72 hours after a second bout of strenuous concentric exercise on bicycle (exercise #2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: male
- •Age ≥ 18 and ≤ 40 years
- •BMI ≥ 18.5 and < 27,5 kg/m2 (WHO standard for normal range BMI)
- •Maximum relative oxygen uptake (VO2max) < 53 ml/kg x min
- •General state of good health
- •Non-smoker
- •Medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry
- •Willingness to provide signed informed consent
排除标准
- •Weekly training volume ≥ 6 hours
- •Use of dietary supplements (incl. high-dosed vitamins and minerals)
- •Chronic immune deficiency
- •Current infection
- •Heart and/or circulation disorders
- •Abnormal findings on exercise ECG
- •Musculoskeletal disorders
- •Any current clinical condition that requires systemic treatment or might have an impact on study objectives
- •Hypersensitivity to botanicals of the Compositae family (e.g. Echinacea)
- •Lactose intolerance
- •Illicit drug or alcohol abuse
- •Participation in another clinical trial within 4 weeks prior to study entry
研究组 & 干预措施
Traumeel
Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
干预措施: Traumeel (Drug)
Placebo
The Placebo tablets (300 mg lactose monohydrate and 1,5 mg magnesium stearate) by mouth the total amount for 72 hours will be 26 tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
时间窗: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
时间窗: 72 hours
次要结局
- Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)(72 hours)
- Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)(72 hours)
- Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)(72 hours)
- Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)(72 hours)
- Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings(72-hours)
研究者
Prof. Dr. med. Frank Christoph Mooren
Prof. Dr. med. Frank Christoph Mooren
University of Giessen