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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Identifier:
First received: December 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study

Metabolic Syndromes

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Estimated Enrollment: 240
Study Start Date: November 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
the group of Jiangzhuo prescription
the group of fenofibrate
the group of placebo

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.

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

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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Please refer to this study by its identifier: NCT01265160

Contact: Fengmei Lian, PHD 0086-010-88001402

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   
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

Responsible Party: Guang'anmen Hospital of China Academy of Chinese Medical Sciences Identifier: NCT01265160     History of Changes
Other Study ID Numbers: 81929
Study First Received: December 22, 2010
Last Updated: December 22, 2010

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on May 25, 2017