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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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 on bicycle (exercise #2).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prof. Dr. med. Frank Christoph Mooren
• Collaborators: Biologische Heilmittel Heel GmbH; University of Giessen

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