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

Coronary Heart Disease Clinical Trial

Official title:

Study on the Relation Between Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease and Its Biological Basis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526381
• Other study ID #: 2014CB542902
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2015
• Last updated: November 19, 2015
• Start date: July 2015
• Est. completion date: August 2018

Study information

• Verified date: November 2015
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: Chunquan Yu, Dr.
• Phone: 8622-59596309
• Email: ycq-4[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
China	Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease		12 weeks	No
Primary	Seattle Angina Questionnaire		12 weeks	No
Primary	The Short Form (36) Health Survey, (SF-36)		12 weeks	No
Primary	Self-reporting Inventory(symptom checklist-90)		12 weeks	No