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

Phase 1CompletedNCT01921777

Prof. Dr. med. Frank Christoph Mooren95 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Exercise-induced Muscle Soreness

Interventions

TraumeelDRUG

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

PlaceboDRUG

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

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Giessen, Germany

Outcomes

Primary Outcomes

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

Time frame: 72 hours

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

Time frame: 72 hours

Secondary Outcomes

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

Time frame: 72 hours

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

Time frame: 72 hours

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

Time frame: 72 hours

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

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

Data from ClinicalTrials.gov

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