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

Primary Purpose

Exercise-induced Muscle Soreness

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Traumeel
Placebo
Sponsored by
Prof. Dr. med. Frank Christoph Mooren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise-induced Muscle Soreness focused on measuring Muscle, exercise, soreness, Damage, Traumeel, homeopathy

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Traumeel

Placebo

Arm Description

Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets

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

Outcomes

Primary Outcome Measures

Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2013
Last Updated
January 20, 2014
Sponsor
Prof. Dr. med. Frank Christoph Mooren
Collaborators
Biologische Heilmittel Heel GmbH, University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT01921777
Brief Title
Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. med. Frank Christoph Mooren
Collaborators
Biologische Heilmittel Heel GmbH, University of Giessen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Muscle Soreness
Keywords
Muscle, exercise, soreness, Damage, Traumeel, homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traumeel
Arm Type
Experimental
Arm Description
Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Traumeel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
Time Frame
72 hours
Title
Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)
Time Frame
72 hours
Title
Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
Time Frame
72 hours
Title
Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)
Time Frame
72 hours
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank C. Mooren, Prof. Dr.
Organizational Affiliation
Department of Sports Medicine, Institute of Sports Science, University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sports Medicine, Institute of Sports Science, University of Giessen
City
Giessen
ZIP/Postal Code
35394
Country
Germany

12. IPD Sharing Statement

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

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