Jiangzhuo Prescription ,Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)
Recruitment status was Recruiting
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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) |
| 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 |
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| Contact: Fengmei Lian, PHD | 0086-010-88001402 | lfm565@sohu.com |
| China | |
| Beijing Medical University,DONGZHIMEN Hospital | Recruiting |
| Beijing, China | |
| Contact: Hongfang Liu, PHD 0086-010-84013243 lhfdoctor@sohu.com | |
| Beijing Chinese Medicine Hospital | Recruiting |
| Beijing, China | |
| Contact: Bai Chang, PHD 13611089962 | |
| Civil Aviation General Hospital | Recruiting |
| Beijing, China | |
| Contact: Yu Zhao, PHD 13522424090 | |
| Beijing Ji Shui Tan Hospital | Recruiting |
| Beijing, China | |
| Contact: Xia Wang 13681007636 | |
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 Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
Fenofibrate Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013