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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01265160
First received: December 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


Condition
Metabolic Syndromes
Hyperlipidemia

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01265160     History of Changes
Other Study ID Numbers: 81929
Study First Received: December 22, 2010
Last Updated: December 22, 2010
Health Authority: Traditional Chinese Medicine Administration:China

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

ClinicalTrials.gov processed this record on October 23, 2014