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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01265160
Other study ID # 81929
Secondary ID
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


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, 

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