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

This study has been completed.
Sponsor:
Collaborators:
Biologische Heilmittel Heel GmbH
University of Giessen
Information provided by (Responsible Party):
Prof. Dr. med. Frank Christoph Mooren, University of Giessen
ClinicalTrials.gov Identifier:
NCT01921777
First received: August 6, 2013
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Exercise-induced Muscle Soreness
Drug: Traumeel
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Traumeel
Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921777

Locations
Germany
Department of Sports Medicine, Institute of Sports Science, University of Giessen
Giessen, Germany, 35394
Sponsors and Collaborators
Prof. Dr. med. Frank Christoph Mooren
Biologische Heilmittel Heel GmbH
University of Giessen
Investigators
Principal Investigator: Frank C. Mooren, Prof. Dr. Department of Sports Medicine, Institute of Sports Science, University of Giessen
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Frank Christoph Mooren, University of Giessen
ClinicalTrials.gov Identifier: NCT01921777     History of Changes
Other Study ID Numbers: TEIR-3, 2009-010899-17
Study First Received: August 6, 2013
Last Updated: January 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Muscle
exercise
soreness
Damage
Traumeel
homeopathy

Additional relevant MeSH terms:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 19, 2014