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

NCT ID: NCT01265160

Last Updated: 2010-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Metabolic Syndromes Hyperlipidemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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the group of Jiangzhuo prescription

No interventions assigned to this group

the group of fenofibrate

No interventions assigned to this group

the group of placebo

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

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Beijing Chinese Medicine Hospital

Beijing, , China

Site Status RECRUITING

Beijing Ji Shui Tan Hospital

Beijing, , China

Site Status RECRUITING

Beijing Medical University,DONGZHIMEN Hospital

Beijing, , China

Site Status RECRUITING

Civil Aviation General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fengmei Lian, PHD

Role: CONTACT

Phone: 0086-010-88001402

Email: [email protected]

Facility Contacts

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Bai Chang, PHD

Role: primary

Xia Wang

Role: primary

Hongfang Liu, PHD

Role: primary

Yu Zhao, PHD

Role: primary

Other Identifiers

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81929

Identifier Type: -

Identifier Source: org_study_id