Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-04-13 @ 5:35 AM
Study NCT ID:
NCT02182934
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline-adjusted half-time hemoglobin re-oxygenation', 'timeFrame': 'day 84'}], 'secondaryOutcomes': [{'measure': 'Baseline-adjusted half-time hemoglobin re-oxygenation', 'timeFrame': 'day 21, 42 and 63'}, {'measure': 'maximum endurance time', 'timeFrame': 'day 21, day 42, day 63 and day 84'}, {'measure': 'Change from baseline in respiratory threshold', 'timeFrame': 'Baseline, up to day 84'}, {'measure': 'Change from baseline in thiobarbituric acid (TBARS)', 'timeFrame': 'Baseline, up to day 84'}, {'measure': 'Change from baseline in glutathione superdismutase/glutathione superdismutase oxidised (GSG/GSSG) ratio', 'timeFrame': 'Baseline, up to day 84'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people and to assess the safety of the product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female volunteers between 18 and 40 years old\n* Females must test negative for pregnancy\n* Recreational athletes according to the american college of sports medicine (ACSM) definition\n* Familiar with the cycle ergometer exercise methodology\n* Written inform consent according to good clinical practice (GCP) and local regulations\n\nExclusion Criteria:\n\n* Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology\n* Alcohol and drug abuse as stated in the clinical trial manual\n* Smokers\n* Known hypertension\n* Known hypercholesterolemia (moderate/severe)\n* Female volunteers taking oral or injectable contraceptives\n* Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \\[intrauterine devices (IUDs)\\]\n* Pregnancy and/or lactation\n* Liver and/or renal and/or vascular disease\n* Relevant allergy or known hypersensitivity to the investigational drug or its excipients\n* Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02182934', 'briefTitle': 'Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Recreational Sports People: a Double-blind, Placebo Controlled Pilot Study', 'orgStudyIdInfo': {'id': '1020.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginsana', 'interventionNames': ['Drug: Ginsana']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ginsana', 'type': 'DRUG', 'armGroupLabels': ['Ginsana']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}