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

NCT01265160 | Unknown DMC

• 1 other identifier: 81929
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Metabolic Syndromes; Hyperlipidemia

Study Arms (3)

the group of Jiangzhuo prescription

the group of fenofibrate

the group of placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Combined metabolic syndrome in patients with hyperlipidemia

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (4)

Beijing Chinese Medicine Hospital

Beijing, China

RECRUITING

Beijing Ji Shui Tan Hospital

Beijing, China

RECRUITING

Beijing Medical University,DONGZHIMEN Hospital

Beijing, China

RECRUITING

Civil Aviation General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Hyperlipidemias

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders

Central Study Contacts

Fengmei Lian, PHD

CONTACT

0086-010-88001402; lfm565@sohu.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 23, 2010

Record last verified: 2010-09

Locations

CN (4)