Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-17 @ 7:04 PM
Study NCT ID:
NCT00808860
Status:
COMPLETED
Last Update Posted:
2010-12-06
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting plasma glucose', 'timeFrame': '12 weeks'}, {'measure': 'HbA1C (glycosylated hemoglobin)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'liver enzymes (AST, ALT)', 'timeFrame': '12 weeks'}, {'measure': 'kidney function (S-creatinine, S-BUN)', 'timeFrame': '12 weeks'}, {'measure': 'plasma lipids (TG, Cholesterol, HDL-, LDL-)', 'timeFrame': '12 weeks'}, {'measure': 'blood pressure', 'timeFrame': '12 weeks'}, {'measure': 'body weight (BMI, hip-weight ratio)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Herbal medicine', 'Type 2 diabetes', 'Gynostemma pentaphyllum Tea', 'Insulin sensitivity', 'add-on'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20213586', 'type': 'BACKGROUND', 'citation': 'Huyen VT, Phan DV, Thang P, Hoa NK, Ostenson CG. Antidiabetic effect of Gynostemma pentaphyllum tea in randomly assigned type 2 diabetic patients. Horm Metab Res. 2010 May;42(5):353-7. doi: 10.1055/s-0030-1248298. Epub 2010 Mar 8.'}, {'pmid': '19536359', 'type': 'BACKGROUND', 'citation': 'Hoa NK, Phan DV, Thuan ND, Ostenson CG. Screening of the hypoglycemic effect of eight Vietnamese herbal drugs. Methods Find Exp Clin Pharmacol. 2009 Apr;31(3):165-9. doi: 10.1358/mf.2009.31.3.1362514.'}, {'pmid': '17283239', 'type': 'RESULT', 'citation': 'Hoa NK, Norberg A, Sillard R, Van Phan D, Thuan ND, Dzung DT, Jornvall H, Ostenson CG. The possible mechanisms by which phanoside stimulates insulin secretion from rat islets. J Endocrinol. 2007 Feb;192(2):389-94. doi: 10.1677/joe.1.06948.'}, {'pmid': '15220351', 'type': 'RESULT', 'citation': 'Norberg A, Hoa NK, Liepinsh E, Van Phan D, Thuan ND, Jornvall H, Sillard R, Ostenson CG. A novel insulin-releasing substance, phanoside, from the plant Gynostemma pentaphyllum. J Biol Chem. 2004 Oct 1;279(40):41361-7. doi: 10.1074/jbc.M403435200. Epub 2004 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.', 'detailedDescription': 'In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animal, the investigators have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, the investigators also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed, drug-naive patients with type 2 diabetes\n* Fasting plasma glucose (FPG)9.0-14.0 mmol/L\n* HbA1C 9-13%\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Liver failure\n* Kidney failure'}, 'identificationModule': {'nctId': 'NCT00808860', 'briefTitle': 'Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': 'Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'Diabetes II-Study 2'}, 'secondaryIdInfos': [{'id': 'Study 2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Gliclazide + Placebo tea', 'interventionNames': ['Dietary Supplement: Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GP group', 'description': 'Gliclazide + Gynostemma pentaphyllum tea', 'interventionNames': ['Dietary Supplement: GP group']}], 'interventions': [{'name': 'GP group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally', 'armGroupLabels': ['GP group']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Institute of Gerontology, HMU', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Claes-Goran Ostenson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Swedish International Development Cooperation Agency (SIDA)', 'class': 'OTHER_GOV'}]}}}