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

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