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

Hypertension Clinical Trial

— JZQG  

Official title:

Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01082835
• Other study ID #: 0081122
• Status: Not yet recruiting
• Phase: N/A
• First received: March 8, 2010
• Last updated: March 15, 2010
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: March 2010
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Fenglian Li, PHD
• Phone: 0086-010-88001402
• Email: lfm565[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Traditional Chinese Medicine Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China,