Clinical Study On The Relation Among Prescription, Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease

NCT ID: NCT02526381

Last Updated: 2015-11-20

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

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-08-31

Brief Summary

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Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood coagulation function evaluation of the relationship between disease and biochemical basis, detect plasma metabonomics and the gene expression profile chip, with "phlegm - lipid metabolic disorder", "stasis - microcirculation disorder", "alternating knot - inflammation mediated" and other system related to the biological basis. With Danlou Tablet for treatment, the investigators can observe result/effect index of turbid phlegm and blood stasis syndrome. Through comprehensive comparison of multi-level, multi-targets and multi-date biological index to discuss its sickness-syndrome-prescription corresponding relation and its biological basis.

Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Danlou Tablets

Danlou prescription is a tablet, each piece weighs 0.3 g, taken orally, three times a day, five at a time, from jilin Cornell's pharmaceutical corporation, Limited Liability Company .

Group Type EXPERIMENTAL

Danlou Tablets

Intervention Type DRUG

Five tablets of Danlou Tablets (1.5g) will be given three times a day in addition to regular western medications for the 8 weeks

Tongmai Yangxin Pills

Tongmai Yangxin prescription is a pill,each pill weighs 0.1 g,taken orally, 2 times a day,40 pills at a time,produced by tianjin new pharmaceutical group corporation, Limited Liability Company . LeRenTang pharmaceutical.

Group Type EXPERIMENTAL

Tongmai Yangxin Pills

Intervention Type DRUG

Forty pills of Tongmai Yangxin Pills (4g) will be given two times a day in addition to regular western medications for the 8 weeks

no drugs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Danlou Tablets

Five tablets of Danlou Tablets (1.5g) will be given three times a day in addition to regular western medications for the 8 weeks

Intervention Type DRUG

Tongmai Yangxin Pills

Forty pills of Tongmai Yangxin Pills (4g) will be given two times a day in addition to regular western medications for the 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Selecting people aged between 35 and 65;
2. Being up to the western diagnostic standard of chronic stable angina(complying with one or more of the following ): 1) There is a clear history of old myocardial infarction; 2) Have undergone coronary angiography or coronary Computed Tomography angiography(CTA) inspection hint antrum of coronary artery with at least a major branch pipe diameter stenosis≥50%; 3) Have received percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting(CABG) treatment.
3. They should sign the informed consent.

Exclusion Criteria

1. Had history of myocardial infarction or unstable angina, or coronary artery revascularization in 3 months.(coronary artery bypass graft or angioplasty);
2. With other diseases that might cause chest pain, including heart diseases, neurosis, menopausal syndrome,hyperthyroidism, Cervical vertebra sickness (arteria vertebrals and spinal cord), gastroesophageal reflux disease or hiatal hernia.
3. Using three or more of these drugs,namely beta blockers, calcium channel blockers, Energy metabolism drugs,and nitrate medications;
4. With hypertension and blood pressure after Anti-hypertensive Medical Therapy is still on the high side (systolic pressure ≥160 mmHg,diastolic pressure ≥100 mmHg)combined with severe cardiopulmonary insufficiency or severe arrhythmia (Rapid auricular fibrillation, atrial flutter or Paroxysmal Supra VentricularTachycardia);
5. Having liver disease or with unexplained serum transaminase continually increasing, or alanine aminotransferase(ALT) and aspartate aminotransferase (AST) greater than 2-fold of the upper limit of normal reference value;
6. Abnormal renal function;
7. Merger of hematopoietic system diseases, or a serious primary diseases such as malignant tumor;
8. Pregnant women, nursing mothers, or there is a requirement for fertility of women of childbearing age;
9. Diabetic kidney disease, severe gouty nephropathy and other metabolic diseases;
10. People with severe metabolic disease;
11. People who are expected with poor medical compliance or can't be visited on a regular basis;
12. Have participated in other clinical trials in recent 3 months;
13. Researchers considering there are other cases in which people are not suitable for attending the trial.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chunquan Yu

Director,Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunquan Yu, Dr.

Role: CONTACT

8622-59596309

Facility Contacts

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Chunquan Yu, Dr.

Role: primary

8622-59596309

Other Identifiers

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2014CB542902

Identifier Type: -

Identifier Source: org_study_id