Overview

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