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

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Danlou Tablets

Tongmai Yangxin Pills

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Tianjin University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Danlou Tablets

Tongmai Yangxin Pills

no drugs

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

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

Seattle Angina Questionnaire

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

Self-reporting Inventory(symptom checklist-90)

Secondary Outcome Measures

Full Information

NCT ID

NCT02526381

First Posted

August 14, 2015

Last Updated

November 19, 2015

Sponsor

Tianjin University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02526381

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Danlou Tablets

Arm Type

Experimental

Arm Description

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 .

Arm Title

Tongmai Yangxin Pills

Arm Type

Experimental

Arm Description

Arm Title

no drugs

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Danlou Tablets

Intervention Description

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

Intervention Name(s)

Tongmai Yangxin Pills

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

Seattle Angina Questionnaire

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Self-reporting Inventory(symptom checklist-90)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunquan Yu, Dr.

Phone

8622-59596309

ycq-4@163.com

Facility Information:

Facility Name

Tianjin University of Traditional Chinese Medicine

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300193

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chunquan Yu, Dr.

Phone

8622-59596309

ycq-4@163.com

12. IPD Sharing Statement

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

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