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

NCT ID: NCT01921777

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Traumeel

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

Group Type: EXPERIMENTAL

Traumeel

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biologische Heilmittel Heel GmbH

INDUSTRY

Sponsor Role: collaborator

University of Giessen

OTHER

Sponsor Role: collaborator

Prof. Dr. med. Frank Christoph Mooren

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Frank Christoph Mooren

Prof. Dr. med. Frank Christoph Mooren

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frank C. Mooren, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Giessen, , Germany

Countries

Germany

Other Identifiers

2009-010899-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TEIR-3

Identifier Type: -

Identifier Source: org_study_id