Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
Overview
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).
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 2013
Interventions
- Drug: Traumeel
- oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
- Drug: Placebo
- oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
Arms, Groups and Cohorts
- Experimental: Traumeel
- Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
- Placebo Comparator: 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
Clinical Trial Outcome Measures
Primary Measures
- Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
- Time Frame: 72 hours
- Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
- Time Frame: 72 hours
Secondary Measures
- Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)
- Time Frame: 72 hours
- Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
- Time Frame: 72 hours
- Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)
- Time Frame: 72 hours
- Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)
- Time Frame: 72 hours
- Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings
- Time Frame: 72-hours
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Prof. Dr. med. Frank Christoph Mooren
- Collaborator
- Biologische Heilmittel Heel GmbH
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Prof. Dr. med. Frank Christoph Mooren, Prof. Dr. med. Frank Christoph Mooren – University of Giessen
- Overall Official(s)
- Frank C. Mooren, Prof. Dr., Principal Investigator, Department of Sports Medicine, Institute of Sports Science, University of Giessen
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.