Status:
COMPLETED
Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
Lead Sponsor:
Prof. Dr. med. Frank Christoph Mooren
Collaborating Sponsors:
Biologische Heilmittel Heel GmbH
University of Giessen
Conditions:
Exercise-induced Muscle Soreness
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01921777
Start Date
January 1 2010
End Date
December 1 2013
Last Update
January 22 2014
Active Locations (1)
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1
Department of Sports Medicine, Institute of Sports Science, University of Giessen
Giessen, Germany, 35394