Clinical trial NCT01082835: Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study
Official title: Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Metabolic Syndrome
Keywords: Chinese herbs
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Combined metabolic syndrome in patients with essential hypertension

Brief summary: Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study.

Detailed description: Charged by the five research centers in line with traditional Chinese medicine hepatogastric Damp-heat syndrome 240 cases have hypertension, and overweight, as well as blood lipid disorders or diabetes were randomly divided into Chinese herbal compound Jiangzhuo Qinggan prescription group and western medicine irbesartan group.The treatment groups were compared 4-week step-down and regulation of blood lipids, blood sugar effect.

Eligibility criteria: Inclusion Criteria:

1. Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.
2. Aged 18-65 years old.
3. Body mass index (BMI) ≥ 24kg/m2, but \<35 kg/m2.
4. Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).
5. Comply with any of the following 3 : triglyceride (TG) elevated levels of:\> 150mg/dl (1.7mmol / l), or has received appropriate treatment; high-density lipoprotein - cholesterol (HDL-C) levels reduced: Men \<40mg/dl (0.9mmol / l), women \<50mg/dl (1.1mmol / l), or has received appropriate treatment; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.
6. Hepatogastric Damp-heat syndrome differentiation.
7. To sign informed consent.

Exclusion Criteria:

1. Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.
2. Nearly 3 months, weight loss ≥ 5%.
3. Suffering from congenital heart disease, rheumatic heart disease, congestive heart failure, unstable angina, and had a myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or off-line clinical significance of arrhythmia.
4. Bilateral renal artery stenosis, solitary kidney, serum creatinine\> 133μmol / L .
5. Active liver disease, history of chronic persistent hepatitis, ALT\> upper limit of normal.
6. Peptic ulcer or malabsorption syndrome .
7. With insulin-treated diabetes.
8. There is a history of appetite or abuse of laxatives by hyperthyroidism.
9. Pregnancy, pregnancy or breast-feeding women to prepare.
10. For those who are allergic Chinese medicine, allergic people.
11. Mentally ill.
12. Hyperkalemia in patients.
13. Cancer.
14. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA).
15. Nearly 3 months in patients receiving other clinical studies.
16. Alcohol and / or psychoactive substances, drug abuse and dependency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Medical University ,Dongzhimen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Medical University,Dongfang Hospital
state: Beijing
city: Beijing
country: China
facility: China Academy of Chinese Medical Sciences,Guang'anmen Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital
state: Beijing
city: Beijng
country: China
facility: Capital University of Medical, Anzhen Hospital
state: Beijing
Study officials:
References: