Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study

• Conditions: Hypertension; Metabolic Syndrome

• Registration Number: NCT01082835
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Last Update Submitted: 2010-03-15
• Last Update Posted: 2010-03-16
• Primary Completion: 2010-07
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Beijing Medical University ,Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Medical University,Dongfang Hospital; 🇨🇳 Beijing, Beijing, China

China Academy of Chinese Medical Sciences,Guang'anmen Hospital; 🇨🇳 Beijing, Beijing, China

Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital; 🇨🇳 Beijing, Beijing, China

Capital University of Medical, Anzhen Hospital; 🇨🇳 Beijng, Beijing, China