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

NCT02526381 | Unknown DMC

• 1 other identifier: 2014CB542902
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (4)

• Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease

  12 weeks

• Seattle Angina Questionnaire

  12 weeks

• The Short Form (36) Health Survey, (SF-36)

  12 weeks

• Self-reporting Inventory(symptom checklist-90)

  12 weeks

Study Arms (3)

Danlou Tablets

EXPERIMENTAL

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

Tongmai Yangxin Pills

EXPERIMENTAL

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

no drugs

NO INTERVENTION

Interventions

Danlou Tablets 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

Danlou Tablets

Tongmai Yangxin Pills 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

Tongmai Yangxin Pills

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Selecting people aged between 35 and 65;
• 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.
• They should sign the informed consent.

You may not qualify if:

• Had history of myocardial infarction or unstable angina, or coronary artery revascularization in 3 months.(coronary artery bypass graft or angioplasty);
• 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.
• Using three or more of these drugs,namely beta blockers, calcium channel blockers, Energy metabolism drugs，and nitrate medications;
• 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);
• 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;
• Abnormal renal function;
• Merger of hematopoietic system diseases, or a serious primary diseases such as malignant tumor;
• Pregnant women, nursing mothers, or there is a requirement for fertility of women of childbearing age;
• Diabetic kidney disease, severe gouty nephropathy and other metabolic diseases;
• People with severe metabolic disease;
• People who are expected with poor medical compliance or can't be visited on a regular basis;
• Have participated in other clinical trials in recent 3 months;
• Researchers considering there are other cases in which people are not suitable for attending the trial.

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Chunquan Yu, Dr.

CONTACT

8622-59596309; ycq-4@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Clinical Research

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 18, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

CN (1)