Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT01912469
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2013-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Traumeel®S Tablets on Exercise Induced Muscle Damage and Muscle Soreness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C433370', 'term': 'Traumeel S'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in post-exercise two baseline levels up to 72-hours of primary muscle damage marker creatine kinase (CK)', 'timeFrame': '72 hours'}, {'measure': 'Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Changes in post-exercise two baseline levels up to 72-hours of immunomodulators (35 lab parameters)', 'timeFrame': '72 hours'}, {'measure': 'Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters)', 'timeFrame': '72 hours'}, {'measure': 'Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (thigh flexors and extensors)', 'timeFrame': '72 hours'}, {'measure': 'Changes in post-exercise two baseline levels up to 72-hours of muscle marker Lactate Dehydrogenase', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Muscle', 'exercise', 'soreness', 'Damage', 'Traumeel'], 'conditions': ['Exercise-induced Muscle Soreness']}, 'referencesModule': {'references': [{'pmid': '27478305', 'type': 'DERIVED', 'citation': 'Muders K, Pilat C, Deuster V, Frech T, Kruger K, Pons-Kuhnemann J, Mooren FC. Effects of Traumeel (Tr14) on Exercise-Induced Muscle Damage Response in Healthy Subjects: A Double-Blind RCT. Mediators Inflamm. 2016;2016:1693918. doi: 10.1155/2016/1693918. Epub 2016 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise test on downhill treadmill.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: male\n* Age ≥ 18 and ≤ 40 years\n* BMI ≥ 18.5 and \\< 27,5 kg/m2 (WHO standard for normal range BMI) \\[48\\]\n* Maximum relative oxygen uptake (VO2max) \\< 53 ml/kg x min\n* General state of good health\n* Non-smoker\n* Medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry\n* Willingness to provide signed informed consent\n\nExclusion Criteria:\n\n* Regular eccentric exercise training\n* Weekly training volume ≥ 6 hours\n* Use of dietary supplements (incl. high-dosed vitamins and minerals)\n* Chronic immune deficiency\n* Current infection\n* Heart and/or circulation disorders\n* Abnormal findings on exercise ECG\n* Musculoskeletal disorders\n* Any current clinical condition that requires systemic treatment or might have an impact on study objectives\n* Hypersensitivity to botanicals of the Compositae family (e.g. Echinacea)\n* Lactose intolerance\n* Illicit drug or alcohol abuse\n* Participation in another clinical trial within 4 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT01912469', 'briefTitle': 'Effects of Traumeel®S Tablets on Exercise Induced Muscle Damage and Muscle Soreness', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'orgStudyIdInfo': {'id': 'TEIR-2'}, 'secondaryIdInfos': [{'id': '2009-010898-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traumeel', 'description': 'Traumeel tablets by mouth the total amount for 72 hours will be 26 tablets', 'interventionNames': ['Drug: Traumeel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', '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', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Traumeel', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Traumeel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35394', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Department of Sports Medicine, Institute of Sports Science, University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Frank C. Mooren, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Sports Medicine, Institute of Sports Science, University of Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. med. Frank Christoph Mooren', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biologische Heilmittel Heel GmbH', 'class': 'INDUSTRY'}, {'name': 'University of Giessen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Frank Christoph Mooren', 'investigatorFullName': 'Prof. Dr. med. Frank Christoph Mooren', 'investigatorAffiliation': 'University of Giessen'}}}}