Exercise-induced Muscle SorenessPhase 1NCT01921777
Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
A Phase 1 study testing Traumeel in people with Exercise-induced Muscle Soreness, run by Prof. Dr. med. Frank Christoph Mooren at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Muscle Soreness
- What is being tested?
- Traumeel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Institute of Sports Science, University of Giessen
Giessen, 35394
About this study
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
- Being tested
- Traumeel, Placebo
- Keywords
- Muscle, exercise, soreness, Damage, Traumeel, homeopathy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraumeelDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Traumeel | Experimental | Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
Measured: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
Measured: 72 hours
Secondary outcomes (5)
Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)
Measured: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
Measured: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)
Measured: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)
Measured: 72 hours
Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings
Measured: 72-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Frank Christoph Mooren
- Sponsor type
- University, hospital or other
- Collaborators
- Biologische Heilmittel Heel GmbH, University of Giessen
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Frank Christoph Mooren, University of Giessen
- Investigators
- Frank C. Mooren, Prof. Dr., Principal investigator, Department of Sports Medicine, Institute of Sports Science, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921777
- Sponsor's protocol ID
- TEIR-3
- Other IDs
- 2009-010899-17, 2009
- Status last verified
- Jan 2014
- First submitted
- 6 Aug 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise
- ClinicalTrials.gov ID
- NCT01921777
- Acronym / sponsor ID
- TEIR-3
- Conditions
- Exercise-induced Muscle Soreness
- Keywords
- Muscle, exercise, soreness, Damage, Traumeel, homeopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Prof. Dr. med. Frank Christoph MoorenUniversity, hospital or other
- Collaborators
- Biologische Heilmittel Heel GmbH, University of Giessen
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumeel | Experimental | Drug: TraumeelTraumeel tablets by mouth the total amount for 72 hours will be 26 tablets |
| Placebo | Placebo comparator | Drug: PlaceboThe Placebo tablets (300 mg lactose monohydrate and 1,5 mg magnesium stearate) by mouth the total amount for 72 hours will be 26 tablets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traumeeloral, 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 | Drug | Traumeel |
| Placebooral, 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 | Drug | Placebo |
Primary outcome
Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra)
Time frame: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6)
Time frame: 72 hours
5 secondary outcomes
Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters)
Time frame: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)
Time frame: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters)
Time frame: 72 hours
Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors)
Time frame: 72 hours
Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings
Time frame: 72-hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Exercise-induced Muscle Soreness
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Not yet recruiting
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
Delayed Onset Muscle Soreness Experimentally Induced
Not yet recruiting
Effects of Hydrogen-rich Water Consumption on Transient Fatigue During an Official Football Match.
Exercise-Induced Fatigue, Football Performance
RecruitingObservational study
The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls
Insomnia, Healthy Adult
RecruitingObservational study
The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain
Insomnia, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank C. Mooren, Prof. Dr. principal investigator
Department of Sports Medicine, Institute of Sports Science, University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Traumeel in people with Exercise-induced Muscle Soreness, run by Prof. Dr. med. Frank Christoph Mooren at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.