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

Phase 1

Completed

• Conditions: Exercise-induced Muscle Soreness
• Interventions: Drug: Placebo; Drug: Traumeel

• Registration Number: NCT01912469
• Lead Sponsor: Prof. Dr. med. Frank Christoph Mooren

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-31
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Traumeel	Traumeel	Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets

Primary Outcome Measures

Name	Time	Method
Changes in post-exercise two baseline levels up to 72-hours of primary muscle damage marker creatine kinase (CK)	72 hours
Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings	72 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Sports Medicine, Institute of Sports Science, University of Giessen; 🇩🇪 Giessen, Germany