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

Hyperlipidemia Clinical Trial

— JZF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265160
• Other study ID #: 81929
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 22, 2010
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2010
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Fengmei Lian, PHD
• Phone: 0086-010-88001402
• Email: lfm565[@]sohu.com
• Is FDA regulated: No
• Health authority: Traditional Chinese Medicine Administration:China
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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, ß-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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Metabolic Syndrome X
• Metabolic Syndromes
• Syndrome

Locations

Country	Name	City	State
China	Beijing Chinese Medicine Hospital	Beijing
China	Beijing Ji Shui Tan Hospital	Beijing
China	Beijing Medical University,DONGZHIMEN Hospital	Beijing
China	Civil Aviation General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China,