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

Exercise-induced Muscle Soreness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921777
• Other study ID #: TEIR-3
• Secondary ID: 2009-010899-17
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2013
• Last updated: January 20, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• 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 recovery and inflammatory immune response over a period of 72 hours after a second bout of strenuous concentric exercise on bicycle (exercise #2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2013
• Est. primary completion date: December 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)

• 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

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 Interleukin-1 receptor antagonist (IL-1ra)		72 hours	No
Primary	Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of other 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 muscle damage markers (2 lab parameters)		72 hours	No
Secondary	Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)		72 hours	No
Secondary	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