search
Back to results

Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise (2012-005003-40)

Primary Purpose

Muscle Injury, Muscle Soreness, Exercise Induced Muscle Damage

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Wobenzym® plus
Placebo
Sponsored by
Mucos Pharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Injury focused on measuring Muscle soreness, Exercise induced muscle damage, Inflammation, Proteolytic enzymes, Muscle strength Dynamometer

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
  • Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
  • Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
  • Non smoker
  • Men with strength training experience
  • Age: 20-50 years
  • BMI ≥20 kg/m2 and ≤ 32 kg/m2
  • medium concentric strength ability (150-300 Nm)

Exclusion Criteria:

  • Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture.
  • No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial
  • Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2.
  • For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening
  • Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance)
  • Drug, alcohol and/or medication abuse
  • Known HIV-infection
  • Known acute or chronic hepatitis B and C infection
  • Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
  • Blood donation within 4 weeks prior to trial start (visit 1) or during trial.

Sites / Locations

  • Sportschule FFb Puch GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wobenzym® plus

Placebo equates Wobenzym® plus but without active ingredients

Arm Description

Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)

3x4 capsules/ day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximal concentric strength (Nm) before and after the stress test
Reduction of strength induced by the excentric stress test
Pressure induced pain
Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure
Blood routine parameters
Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters
blood pressure
Blood pressure and heart rate as safety parameter
Movement induced pain
Pain induced by a standardised movement and rated by the volunteer via VAS.

Full Information

First Posted
April 23, 2013
Last Updated
August 27, 2015
Sponsor
Mucos Pharma GmbH & Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT01845558
Brief Title
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
Acronym
2012-005003-40
Official Title
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mucos Pharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury, Muscle Soreness, Exercise Induced Muscle Damage
Keywords
Muscle soreness, Exercise induced muscle damage, Inflammation, Proteolytic enzymes, Muscle strength Dynamometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wobenzym® plus
Arm Type
Experimental
Arm Description
Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)
Arm Title
Placebo equates Wobenzym® plus but without active ingredients
Arm Type
Placebo Comparator
Arm Description
3x4 capsules/ day
Intervention Type
Drug
Intervention Name(s)
Wobenzym® plus
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
immediately before, 24h post, 48h post
Secondary Outcome Measure Information:
Title
Maximal concentric strength (Nm) before and after the stress test
Description
Reduction of strength induced by the excentric stress test
Time Frame
immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Title
Pressure induced pain
Description
Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure
Time Frame
immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Title
Blood routine parameters
Description
Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters
Time Frame
immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Title
blood pressure
Description
Blood pressure and heart rate as safety parameter
Time Frame
immediately before, 24h, 48h, 72h
Title
Movement induced pain
Description
Pain induced by a standardised movement and rated by the volunteer via VAS.
Time Frame
immediately before, 0h, 3h, 6h, 24h, 48h, 72h post

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is able and willing to sign the Informed Consent Form prior to screening evaluations Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study Non smoker Men with strength training experience Age: 20-50 years BMI ≥20 kg/m2 and ≤ 32 kg/m2 medium concentric strength ability (150-300 Nm) Exclusion Criteria: Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture. No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2. For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance) Drug, alcohol and/or medication abuse Known HIV-infection Known acute or chronic hepatitis B and C infection Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial Blood donation within 4 weeks prior to trial start (visit 1) or during trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Pabst, Dr. med
Organizational Affiliation
PWC GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sportschule FFb Puch GmbH
City
Fürstenfeld Bruck
ZIP/Postal Code
82256
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise

We'll reach out to this number within 24 hrs