Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
- Registration Number
- NCT01921777
- Lead Sponsor
- Prof. Dr. med. Frank Christoph Mooren
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 95
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traumeel Traumeel Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets Placebo 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
- Primary Outcome Measures
Name Time Method Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) 72 hours Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6) 72 hours
- Secondary Outcome Measures
Name Time Method 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 maximum isometric strength (separately for thigh flexors and extensors) 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 Short Form McGill Questionnaire total scores and separate VAS pain ratings 72-hours
Trial Locations
- Locations (1)
Department of Sports Medicine, Institute of Sports Science, University of Giessen
🇩🇪Giessen, Germany