Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 6:23 AM
Study NCT ID:
NCT01082835
Status:
UNKNOWN
Last Update Posted:
2010-03-16
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-15', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chinese herbs'], 'conditions': ['Hypertension', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study.', 'detailedDescription': 'Charged by the five research centers in line with traditional Chinese medicine hepatogastric Damp-heat syndrome 240 cases have hypertension, and overweight, as well as blood lipid disorders or diabetes were randomly divided into Chinese herbal compound Jiangzhuo Qinggan prescription group and western medicine irbesartan group.The treatment groups were compared 4-week step-down and regulation of blood lipids, blood sugar effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Combined metabolic syndrome in patients with essential hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.\n2. Aged 18-65 years old.\n3. Body mass index (BMI) ≥ 24kg/m2, but \\<35 kg/m2.\n4. Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).\n5. Comply with any of the following 3 : triglyceride (TG) elevated levels of:\\> 150mg/dl (1.7mmol / l), or has received appropriate treatment; high-density lipoprotein - cholesterol (HDL-C) levels reduced: Men \\<40mg/dl (0.9mmol / l), women \\<50mg/dl (1.1mmol / l), or has received appropriate treatment; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.\n6. Hepatogastric Damp-heat syndrome differentiation.\n7. To sign informed consent.\n\nExclusion Criteria:\n\n1. Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.\n2. Nearly 3 months, weight loss ≥ 5%.\n3. Suffering from congenital heart disease, rheumatic heart disease, congestive heart failure, unstable angina, and had a myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or off-line clinical significance of arrhythmia.\n4. Bilateral renal artery stenosis, solitary kidney, serum creatinine\\> 133μmol / L .\n5. Active liver disease, history of chronic persistent hepatitis, ALT\\> upper limit of normal.\n6. Peptic ulcer or malabsorption syndrome .\n7. With insulin-treated diabetes.\n8. There is a history of appetite or abuse of laxatives by hyperthyroidism.\n9. Pregnancy, pregnancy or breast-feeding women to prepare.\n10. For those who are allergic Chinese medicine, allergic people.\n11. Mentally ill.\n12. Hyperkalemia in patients.\n13. Cancer.\n14. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA).\n15. Nearly 3 months in patients receiving other clinical studies.\n16. Alcohol and / or psychoactive substances, drug abuse and dependency.'}, 'identificationModule': {'nctId': 'NCT01082835', 'acronym': 'JZQG', 'briefTitle': 'Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study', 'orgStudyIdInfo': {'id': '0081122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the group of Jiangzhuo Qinggan prescription'}, {'label': 'the group of irbesartan'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Weixing Lu', 'role': 'CONTACT', 'email': 'weixinglu918@sina.com', 'phone': '0086-013601067938'}], 'facility': 'Beijing Medical University ,Dongzhimen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Qian Lin', 'role': 'CONTACT', 'email': 'dfluyao@126.com', 'phone': '0086-013910565673'}], 'facility': 'Beijing Medical University,Dongfang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Qiang Zhou', 'role': 'CONTACT', 'email': 'tiantianlanzhouqiang@126.com', 'phone': '0086-015101016416'}], 'facility': "China Academy of Chinese Medical Sciences,Guang'anmen Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jianfeng Huang', 'role': 'CONTACT', 'email': 'jianfhuang918@sina.com', 'phone': '0086-010-88396403'}], 'facility': 'Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijng', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhenqiu Yu', 'role': 'CONTACT', 'email': 'yuzhenqiu@yahoo.com.cn', 'phone': '0086-010-64456577'}], 'facility': 'Capital University of Medical, Anzhen Hospital'}], 'centralContacts': [{'name': 'Fenglian Li, PHD', 'role': 'CONTACT', 'email': 'lfm565@sohu.com', 'phone': '0086-010-88001402'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "Guang'anmen Hospital", 'oldOrganization': 'China Academy of Chinese Medical Sciences'}}}}