Effects of Traumeel®S Tablets on Exercise Induced Muscle Damage and Muscle Soreness

September 12, 2013 updated by: Prof. Dr. med. Frank Christoph Mooren
To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise test on downhill treadmill.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Giessen, Germany, 35394
        • Department of Sports Medicine, Institute of Sports Science, University of Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Sex: male
  • Age ≥ 18 and ≤ 40 years
  • BMI ≥ 18.5 and < 27,5 kg/m2 (WHO standard for normal range BMI) [48]
  • 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:

  • Regular eccentric exercise training
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traumeel
Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
Drug: Traumeel
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
Placebo Comparator: Placebo
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in post-exercise two baseline levels up to 72-hours of primary muscle damage marker creatine kinase (CK)
Time Frame: 72 hours
72 hours
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
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in post-exercise two baseline levels up to 72-hours of immunomodulators (35 lab parameters)
Time Frame: 72 hours
72 hours
Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
Time Frame: 72 hours
72 hours
Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (thigh flexors and extensors)
Time Frame: 72 hours
72 hours
Changes in post-exercise two baseline levels up to 72-hours of muscle marker Lactate Dehydrogenase
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Frank Christoph Mooren

Collaborators

University of Giessen
Biologische Heilmittel Heel GmbH

Investigators

  • Principal Investigator: Frank C. Mooren, Prof. Dr., Department of Sports Medicine, Institute of Sports Science, University of Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEIR-2
  • 2009-010898-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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