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

Exercise-induced Muscle Soreness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912469
• Other study ID #: TEIR-2
• Secondary ID: 2009-010898-21
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2013
• Last updated: September 12, 2013
• Start date: April 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise-induced Muscle Soreness
• Myalgia

Intervention

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
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

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, Institute of Sports Science, University of Giessen	Giessen

Sponsors (3)

Lead Sponsor	Collaborator
Prof. Dr. med. Frank Christoph Mooren	Biologische Heilmittel Heel GmbH, University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in post-exercise two baseline levels up to 72-hours of primary muscle damage marker creatine kinase (CK)		72 hours	No
Primary	Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of immunomodulators (35 lab parameters)		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (thigh flexors and extensors)		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of muscle marker Lactate Dehydrogenase		72 hours	No