HypertensionJZQGNCT01082835
Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study
An observational study of Hypertension and Metabolic Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.
Trial summary
Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Metabolic Syndrome
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Combined metabolic syndrome in patients with essential hypertension
Who may be able to join
- Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.
- Aged 18-65 years old.
- Body mass index (BMI) ≥ 24kg/m2, but <35 kg/m2.
- Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).
- 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.
- Hepatogastric Damp-heat syndrome differentiation.
- To sign informed consent.
Who cannot join
- Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.
- Nearly 3 months, weight loss ≥ 5%.
- 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.
- Bilateral renal artery stenosis, solitary kidney, serum creatinine> 133μmol / L .
- Active liver disease, history of chronic persistent hepatitis, ALT> upper limit of normal.
- Peptic ulcer or malabsorption syndrome .
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- With insulin-treated diabetes.
- There is a history of appetite or abuse of laxatives by hyperthyroidism.
- Pregnancy, pregnancy or breast-feeding women to prepare.
- For those who are allergic Chinese medicine, allergic people.
- Mentally ill.
- Hyperkalemia in patients.
- Cancer.
- Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA).
- Nearly 3 months in patients receiving other clinical studies.
- Alcohol and / or psychoactive substances, drug abuse and dependency.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Medical University ,Dongzhimen Hospital
Beijing, Beijing Municipality
Weixing Lu, 0086-013601067938, weixinglu918@sina.com
Beijing Medical University,Dongfang Hospital
Beijing, Beijing Municipality
Qian Lin, 0086-013910565673, dfluyao@126.com
China Academy of Chinese Medical Sciences,Guang'anmen Hospital
Beijing, Beijing Municipality
Qiang Zhou, 0086-015101016416, tiantianlanzhouqiang@126.com
Chinese Academy of Medical Sciences Fu Wai Cardiovascular Hospital
Beijing, Beijing Municipality
Jianfeng Huang, 0086-010-88396403, jianfhuang918@sina.com
Capital University of Medical, Anzhen Hospital
Beijng, Beijing Municipality
Zhenqiu Yu, 0086-010-64456577, yuzhenqiu@yahoo.com.cn
About this study
Official title: Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study
Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study.
Read the 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.
- Conditions
- Hypertension, Metabolic Syndrome
- Keywords
- Chinese herbs
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the group of Jiangzhuo Qinggan prescription | Not described | |
| the group of irbesartan | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082835
- Sponsor's protocol ID
- 0081122
- Acronym
- JZQG
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT01082835
- Acronym / sponsor ID
- JZQG / 0081122
- Conditions
- Hypertension, Metabolic Syndrome
- Keywords
- Chinese herbs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group of Jiangzhuo Qinggan prescription | – | – |
| the group of irbesartan | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Combined metabolic syndrome in patients with essential hypertension
Key inclusion criteria (7 listed)
- Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.
- Aged 18-65 years old.
- Body mass index (BMI) ≥ 24kg/m2, but <35 kg/m2.
- Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).
- 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.
Key exclusion criteria (16 listed)
- Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.
- Nearly 3 months, weight loss ≥ 5%.
- 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.
- Bilateral renal artery stenosis, solitary kidney, serum creatinine> 133μmol / L .
- Active liver disease, history of chronic persistent hepatitis, ALT> upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Metabolic Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenglian Li, PHD (0086-010-88001402, lfm565@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2010.