Effects of Traumeel®S Tablets on Exercise Induced Muscle Damage and Muscle Soreness
NCT ID: NCT01912469
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2010-04-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Traumeel
Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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Biologische Heilmittel Heel GmbH
INDUSTRY
University of Giessen
OTHER
Prof. Dr. med. Frank Christoph Mooren
OTHER
Responsible Party
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Prof. Dr. med. Frank Christoph Mooren
Prof. Dr. med. Frank Christoph Mooren
Principal Investigators
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Frank C. Mooren, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Sports Medicine, Institute of Sports Science, University of Giessen
Locations
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Department of Sports Medicine, Institute of Sports Science, University of Giessen
Giessen, , Germany
Countries
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References
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Muders K, Pilat C, Deuster V, Frech T, Kruger K, Pons-Kuhnemann J, Mooren FC. Effects of Traumeel (Tr14) on Exercise-Induced Muscle Damage Response in Healthy Subjects: A Double-Blind RCT. Mediators Inflamm. 2016;2016:1693918. doi: 10.1155/2016/1693918. Epub 2016 Jul 5.
Other Identifiers
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2009-010898-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TEIR-2
Identifier Type: -
Identifier Source: org_study_id