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

NCT ID: NCT01082835

Last Updated: 2010-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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the group of Jiangzhuo Qinggan prescription

No interventions assigned to this group

the group of irbesartan

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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China Academy of Chinese Medical Sciences

Locations

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Beijing Medical University ,Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Medical University,Dongfang Hospital

Beijing, Beijing Municipality, China

Site Status

China Academy of Chinese Medical Sciences,Guang'anmen Hospital

Beijing, Beijing Municipality, China

Site Status

Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital

Beijing, Beijing Municipality, China

Site Status

Capital University of Medical, Anzhen Hospital

Beijng, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Fenglian Li, PHD

Role: CONTACT

0086-010-88001402

Facility Contacts

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Weixing Lu

Role: primary

0086-013601067938

Qian Lin

Role: primary

0086-013910565673

Qiang Zhou

Role: primary

0086-015101016416

Jianfeng Huang

Role: primary

0086-010-88396403

Zhenqiu Yu

Role: primary

0086-010-64456577

Other Identifiers

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0081122

Identifier Type: -

Identifier Source: org_study_id

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