Clinical trial NCT01921777: Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Exercise-induced Muscle Soreness
Keywords: Muscle
exercise
soreness
Damage
Traumeel
homeopathy
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Biologische Heilmittel Heel GmbH
name: University of Giessen
First posted: 2013-08-13
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 on bicycle (exercise #2).


Eligibility 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

Primary outcomes:
measure: Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
timeFrame: 72 hours
measure: Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
timeFrame: 72 hours
Secondary outcomes:
measure: Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)
timeFrame: 72 hours
measure: Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
timeFrame: 72 hours
measure: Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)
timeFrame: 72 hours
measure: Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)
timeFrame: 72 hours
measure: Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings
timeFrame: 72-hours
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Department of Sports Medicine, Institute of Sports Science, University of Giessen
Study officials:
affiliation: Department of Sports Medicine, Institute of Sports Science, University of Giessen
name: Frank C. Mooren, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: