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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01082835
First received: March 8, 2010
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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


Condition
Hypertension
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study

Resource links provided by NLM:


Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Estimated Enrollment: 240
Study Start Date: March 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
the group of Jiangzhuo Qinggan prescription
the group of irbesartan

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Combined metabolic syndrome in patients with essential hypertension

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082835

Contacts
Contact: Fenglian Li, PHD 0086-010-88001402 lfm565@sohu.com

Locations
China, Beijing
Beijing Medical University,Dongfang Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Qian Lin    0086-013910565673    dfluyao@126.com   
Beijing Medical University ,Dongzhimen Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Weixing Lu    0086-013601067938    weixinglu918@sina.com   
Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Jianfeng Huang    0086-010-88396403    jianfhuang918@sina.com   
China Academy of Chinese Medical Sciences,Guang'anmen Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Qiang Zhou    0086-015101016416    tiantianlanzhouqiang@126.com   
Capital University of Medical, Anzhen Hospital Not yet recruiting
Beijng, Beijing, China
Contact: Zhenqiu Yu    0086-010-64456577    yuzhenqiu@yahoo.com.cn   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01082835     History of Changes
Other Study ID Numbers: 0081122
Study First Received: March 8, 2010
Last Updated: March 15, 2010
Health Authority: China: Traditional Chinese Medicine Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Chinese herbs

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014