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

Prof. Dr. med. Frank Christoph Mooren

Status and phase: Completed; Phase 1

Conditions: Exercise-induced Muscle Soreness

Treatments: Drug: Placebo; Drug: Traumeel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01921777

2009-010899-17 (EudraCT Number)

TEIR-3

Details and patient eligibility

About

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).

Enrollment: 95 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Traumeel

Experimental group

Description:

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

Treatment:

Drug: Traumeel

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo