Skip to main content
OpenTrials
Completed

NCT Number: NCT01921777

Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exercise-induced Muscle Soreness Behavior Motor Activity

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Sports Medicine, Institute of Sports Science, University of Giessen

Giessen, 35394, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traumeel

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)

    Time frame: 72 hours

  2. Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)

    Time frame: 72 hours

Secondary outcomes

  1. Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)

    Time frame: 72 hours

  2. Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)

    Time frame: 72 hours

  3. Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)

    Time frame: 72 hours

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. med. Frank Christoph Mooren

Other

Collaborators

  • Biologische Heilmittel Heel GmbH
  • University of Giessen

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2013
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.