Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-04 @ 3:29 PM
Study NCT ID:
NCT02007304
Status:
UNKNOWN
Last Update Posted:
2013-12-10
First Post:
2013-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse Wave Velocity', 'timeFrame': 'Before eccentric exercise and training', 'description': 'PWV will be measured before, 6th week, 12th week of eccentric exercise training.'}, {'measure': 'Pulse Wave Velocity', 'timeFrame': '6th week of eccentric exercise traininig', 'description': 'PWV will be measured before, 6th week, 12th week of eccentric exercise training.'}, {'measure': 'Pulse Wave Velocity', 'timeFrame': '12th week of eccentric exercise training', 'description': 'PWV will be measured before, 6th week, 12th week of eccentric exercise training.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Before intervention', 'description': 'Morning blood pressure will be measured before, during, and after 12 week of dietary and eccentric exercise intervention.'}, {'measure': 'Blood pressure', 'timeFrame': '6th week of intervention', 'description': 'Morning blood pressure will be measured before, 6th, and after 12 week of dietary and eccentric exercise intervention.'}, {'measure': 'Blood pressure', 'timeFrame': '12th week of intervention', 'description': 'Morning blood pressure will be measured before, during, and after 12 week of dietary and eccentric exercise intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '27912940', 'type': 'DERIVED', 'citation': 'Lin HF, Chou CC, Chao HH, Tanaka H. Panax ginseng and Salvia miltiorrhiza supplementation during eccentric resistance training in middle-aged and older adults: A double-blind randomized control trial. Complement Ther Med. 2016 Dec;29:158-163. doi: 10.1016/j.ctim.2016.10.003. Epub 2016 Oct 11.'}, {'pmid': '27266702', 'type': 'DERIVED', 'citation': 'Lin HF, Tung K, Chou CC, Lin CC, Lin JG, Tanaka H. Panax ginseng and salvia miltiorrhiza supplementation abolishes eccentric exercise-induced vascular stiffening: a double-blind randomized control trial. BMC Complement Altern Med. 2016 Jun 6;16:168. doi: 10.1186/s12906-016-1139-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of is to determine the preventive effects of Chinese herb supplement with panax ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness and vascular reactivity by using a double-blind randomized control design and to examine the effects of a 12-week progressive eccentric resistance exercise training on arterial elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Healthy sedentary adults\n\nExclusion Criteria:\n\n* obesity (BMI \\>30 kg/m2)\n* smoking within past six months\n* hypertension (high blood pressure \\>140/90 mmHg)\n* personal history of diabetes (fasting blood glucose \\>126 mg/dL), heart disease, or other cardiovascular problems\n* orthopedic injury that may prevent him or her from completing the exercise\n* the use of over-the-counter supplements or vitamins'}, 'identificationModule': {'nctId': 'NCT02007304', 'briefTitle': 'Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Preventing Arterial Stiffening Effects Induced by Acute and Chronic Eccentric Exercise', 'orgStudyIdInfo': {'id': '201112068MIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Herbs', 'description': 'participants assigned to experimental arm will take 300mg panax ginseng and 300mg salvia miltiorrhiza extracts in capsules for 12 weeks along with eccentric exercise training', 'interventionNames': ['Behavioral: Eccentric exercise training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'parcipants in this group will take placebo capsule containing microcrystalline cellulose', 'interventionNames': ['Behavioral: Eccentric exercise training']}], 'interventions': [{'name': 'Eccentric exercise training', 'type': 'BEHAVIORAL', 'description': '12 weeks of lower leg eccentric training', 'armGroupLabels': ['Herbs', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '106', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsin-Fu Lin, Ph.D', 'role': 'CONTACT', 'email': 'hsinfu@ntu.edu.tw', 'phone': '+886932873163'}], 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsin-Fu Lin, Ph.D.', 'role': 'CONTACT', 'email': 'hsinfu@ntu.edu.tw', 'phone': '+886932873163'}], 'overallOfficials': [{'name': 'Hsin-Fu Lin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}