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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02526381
Recruitment Status : Unknown
Verified November 2015 by Chunquan Yu, Tianjin University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : August 18, 2015
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Chunquan Yu, Tianjin University of Traditional Chinese Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Danlou Tablets Drug: Tongmai Yangxin Pills Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Relation Between Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease and Its Biological Basis
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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 .
Drug: 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

Experimental: 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.
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

No Intervention: no drugs

Primary Outcome Measures :
  1. Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease [ Time Frame: 12 weeks ]
  2. Seattle Angina Questionnaire [ Time Frame: 12 weeks ]
  3. The Short Form (36) Health Survey, (SF-36) [ Time Frame: 12 weeks ]
  4. Self-reporting Inventory(symptom checklist-90) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02526381

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Contact: Chunquan Yu, Dr. 8622-59596309

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China, Tianjin
Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300193
Contact: Chunquan Yu, Dr.    8622-59596309   
Sponsors and Collaborators
Tianjin University of Traditional Chinese Medicine

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Responsible Party: Chunquan Yu, Director,Clinical Research, Tianjin University of Traditional Chinese Medicine Identifier: NCT02526381     History of Changes
Other Study ID Numbers: 2014CB542902
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases