Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT01265160
Status:
UNKNOWN
Last Update Posted:
2010-12-23
First Post:
2010-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'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'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-22', 'studyFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metabolic Syndromes', 'Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study', 'detailedDescription': 'Charged by the five research centers in line with traditional Chinese medicine syndrome of phlegm obstruction 240 cases have hyperlipidemia, and overweight, as well as hypertension or diabetes were randomly divided into Chinese herbal compound Jiangzhuo prescription group and western medicine fenofibrate group and placebo group.The treatment groups were compared 12-week regulation of blood lipids and step-down, 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 hyperlipidemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Consistent with diagnosed hyperlipidemia, TG≥2.26mmol/L and ≤7.0mmol/L. 2. Aged 18-65 years old. 3.BMI ≥ 24kg/m2, but \\<35 kg/m2. 4. Waist circumference ≥ 90cm (male) or waist circumference ≥ 80cm (women). 5. Comply with any of the following 3 :bloode pressure elevated levels of:SBP ≥130mmHg or DBP ≥85mmHg; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.\n\nExclusion Criteria:\n\n* 1\\. Has been used to control lipidsdrugs, but use the time for those below the 3 month.\n\n 2.Secondary dyslipidemia, such as nephrotic syndrome, hyperthyroidism, etc. 3.Taking thyroid medications and other drugs that affect lipid metabolism, such as high-dose thiazide diuretics, β-receptor blockers, corticosteroids.\n\n 4.Severe diseases of heart, lung, liver, kidney, brain, blood ,etc. 5.With the treatment of insulin, sulfonylureas, rosiglitazone or metformin. 6.3 months prior to the study of myocardial infarction or unstable angina confirmed.\n\n 7.Uncontrolled blood sugar or after controlling FPG\\>7.0mmol/L or 2hPG\\>11.1mmol/L 8.Uncontrolled blood pressure or after contraolling blood pressure\\>140/90mmHg 9.ALT≥80mmol/L 10.Pregnancy, for pregnancy or breast-feeding women 11.Allergis of fibrates or Chinese medicine 12.Mental illness 13.Cancer patients 14.History of gallbladder disease or cholelithiasis 15.With the treatment of Cyclosporine or coumarin anticoagulants 16.The patient with other clinical studies in the past 3 months 17.History of alcoholism and drug dependence'}, 'identificationModule': {'nctId': 'NCT01265160', 'acronym': 'JZF', 'briefTitle': 'Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)', 'orgStudyIdInfo': {'id': '81929'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the group of Jiangzhuo prescription'}, {'label': 'the group of fenofibrate'}, {'label': 'the group of placebo'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bai Chang, PHD', 'role': 'CONTACT', 'phone': '13611089962'}], 'facility': 'Beijing Chinese Medicine Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xia Wang', 'role': 'CONTACT', 'phone': '13681007636'}], 'facility': 'Beijing Ji Shui Tan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongfang Liu, PHD', 'role': 'CONTACT', 'email': 'lhfdoctor@sohu.com', 'phone': '0086-010-84013243'}], 'facility': 'Beijing Medical University,DONGZHIMEN Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Zhao, PHD', 'role': 'CONTACT', 'phone': '13522424090'}], 'facility': 'Civil Aviation General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fengmei Lian, 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 of China Academy of Chinese Medical Sciences", 'oldOrganization': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}