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Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF) (JZF)

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ClinicalTrials.gov Identifier: NCT01265160
Recruitment Status : Unknown
Verified September 2010 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 23, 2010
Last Update Posted : December 23, 2010
Sponsor:
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description
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Brief Summary:
Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study

Condition or disease
Metabolic Syndromes Hyperlipidemia

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)
Study Start Date : November 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Groups and Cohorts
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Group/Cohort
the group of Jiangzhuo prescription
the group of fenofibrate
the group of placebo


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Combined metabolic syndrome in patients with hyperlipidemia
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1. Has been used to control lipidsdrugs, but use the time for those below the 3 month.

    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.

    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.

    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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265160


Contacts
Contact: Fengmei Lian, PHD 0086-010-88001402 lfm565@sohu.com

Locations
China
Beijing Chinese Medicine Hospital Recruiting
Beijing, China
Contact: Bai Chang, PHD    13611089962      
Beijing Ji Shui Tan Hospital Recruiting
Beijing, China
Contact: Xia Wang    13681007636      
Beijing Medical University,DONGZHIMEN Hospital Recruiting
Beijing, China
Contact: Hongfang Liu, PHD    0086-010-84013243    lhfdoctor@sohu.com   
Civil Aviation General Hospital Recruiting
Beijing, China
Contact: Yu Zhao, PHD    13522424090      
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
More Information
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Responsible Party: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01265160     History of Changes
Other Study ID Numbers: 81929
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Hyperlipidemias
Hyperlipoproteinemias
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents