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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005003-40 | EudraCT Number |
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The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wobenzym® plus | Experimental | Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day) |
|
| Placebo equates Wobenzym® plus but without active ingredients | Placebo Comparator | 3x4 capsules/ day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wobenzym® plus | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test | Multidimensional approach for recovery and acute phase after eccentric stress test. Will be assessed at different time points before and after an excentric stress test and the reduction of these parameters under treatment will be calculated. | immediately before, 24h post, 48h post |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal concentric strength (Nm) before and after the stress test | Reduction of strength induced by the excentric stress test | immediately before, 0h, 3h, 6h, 24h, 48h, 72h |
| Pressure induced pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Pabst, Dr. med | PWC GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sportschule FFb Puch GmbH | Fürstenfeldbruck | 82256 | Germany |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C023295 | Wobenzym |
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|
Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure
| immediately before, 0h, 3h, 6h, 24h, 48h, 72h |
| Blood routine parameters | Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters | immediately before, 0h, 3h, 6h, 24h, 48h, 72h |
| blood pressure | Blood pressure and heart rate as safety parameter | immediately before, 24h, 48h, 72h |
| Movement induced pain | Pain induced by a standardised movement and rated by the volunteer via VAS. | immediately before, 0h, 3h, 6h, 24h, 48h, 72h post |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |