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

NCT01921777 | Completed Phase 1

• 2 other identifiers: TEIR-32009-010899-17
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Exercise-induced Muscle Soreness

Keywords

Muscle; exercise; soreness; Damage; Traumeel; homeopathy

Outcome Measures

Primary Outcomes (2)

• Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)

  72 hours

• Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)

  72 hours

Secondary Outcomes (5)

• Changes in post-exercise two baseline levels up to 72-hours of other 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 damage markers (2 lab parameters)

  72 hours

• Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)

  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

Study Arms (2)

Traumeel

EXPERIMENTAL

Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets

Drug: Traumeel

Placebo

PLACEBO COMPARATOR

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

Interventions

Traumeel DRUG

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

Traumeel

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Frank Christoph Mooren: lead
• Biologische Heilmittel Heel GmbH: collaborator
• University of Giessen: collaborator

Study Sites (1)

Department of Sports Medicine, Institute of Sports Science, University of Giessen

Giessen, 35394, Germany

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Frank C. Mooren, Prof. Dr.

  Department of Sports Medicine, Institute of Sports Science, University of Giessen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Frank Christoph Mooren

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 13, 2013
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

DE (1)