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

Study Overview
=================
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).

Conditions
-----------------
Exercise-induced Muscle Soreness

Intervention / Treatment
-----------------
* Drug: Traumeel
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traumeel<br>Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets | Drug: Traumeel<br>* 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<br>|
| Placebo Comparator: Placebo<br>The Placebo tablets (300 mg lactose monohydrate and 1,5 mg magnesium stearate) by mouth the total amount for 72 hours will be 26 tablets | Drug: Placebo<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) |  | 72 hours | 
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters) |  | 72 hours | 
| Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters) |  | 72 hours | 
| Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters) |  | 72 hours | 
| Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors) |  | 72 hours | 
| Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings |  | 72-hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumeel, Muscle, exercise, soreness, Damage, homeopathy