Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-03 @ 3:49 AM
Study NCT ID:
NCT01664156
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2012-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C569627', 'term': 'Cold Hypersensitivity'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-12', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of the infrared thermography of cold hypersensitivity on hands', 'timeFrame': 'baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'The change of the infrared thermography of cold hypersensitivity on feet', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'The change of cold stress test', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'The change of Distal-Dorsal Difference', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'The change of Heart Rate Variability', 'timeFrame': 'baseline and 8 weeks'}, {'measure': 'The change of 36-Item Short Form Health Survey', 'timeFrame': 'baseline, 8 weeks, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cold hypersensitivity', 'Korean red ginseng', 'Infrared thermography', 'Cold stress test', 'Distal-dorsal difference'], 'conditions': ['Cold Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '22856358', 'type': 'BACKGROUND', 'citation': 'Hur YM, Chae JH, Chung KW, Kim JJ, Jeong HU, Kim JW, Seo SY, Kim KS. Feeling of cold hands and feet is a highly heritable phenotype. Twin Res Hum Genet. 2012 Apr;15(2):166-9. doi: 10.1375/twin.15.2.166.'}, {'pmid': '24354675', 'type': 'DERIVED', 'citation': 'Park KS, Kim JW, Jo JY, Hwang DS, Lee CH, Jang JB, Lee KS, Yeo I, Lee JM. Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial. Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438.'}]}, 'descriptionModule': {'briefSummary': '1. Objectives\n\n 1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women\n 2. to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography\n2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.', 'detailedDescription': 'Design\n\n* This trial is a randomized, double blind, placebo controlled trial with 80 patients.\n* The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea.\n* Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks.\n* During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female aged 16 to 60 years\n2. Women complaining cold hypersensitivity on hands and feet\n3. Thermal deviation between the palm and the upper arm is higher than 0.3℃\n\nExclusion Criteria:\n\n1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography\n2. Alcohol abuse and alcoholic\n3. History of cancer within 5 years\n4. Severe depression\n5. Hypertension and diabetes\n6. Pregnancy or breastfeeding\n7. Abnormal finding from blood test at screening visit\n8. Allergic to Korean red ginseng\n9. Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months'}, 'identificationModule': {'nctId': 'NCT01664156', 'briefTitle': 'Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet', 'organization': {'class': 'OTHER', 'fullName': 'The Korean Society of Ginseng'}, 'officialTitle': 'Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'KHNMC-OH-IRB 2012-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Korean red ginseng', 'description': 'The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).', 'interventionNames': ['Drug: Korean red ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Korean red ginseng', 'type': 'DRUG', 'description': 'Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.', 'armGroupLabels': ['Korean red ginseng']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134 727', 'city': 'Seoul', 'state': 'Gangdong-gu', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JIN-MOO LEE, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Korean Society of Ginseng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JIN-MOO LEE', 'investigatorAffiliation': 'Kyung Hee University Hospital at Gangdong'}}}}