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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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