Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events

Last updated: May 26, 2020
Sponsor: Changchun University of Chinese Medicine
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Thrombosis

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01715376
201007001-3-1
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. the patients who are according with the II、III stage in CHD western medical diagnosisstandard；

  2. age between 18 and 75(including 18 and 75)；

  3. Signed the informed consent voluntarily.

Exclusion

Exclusion Criteria:

  1. The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, havesever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, severarrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventriculartachycardia and so on）；

  2. the patients who have myocardial infarction or vascular remodeling in last 3 months；

  3. hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；

  4. the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/Land/ or random blood glucose>11.0mmol/L）；

  5. the patients who have stroke in late 6 months（lacunar cerebral infarction is notincluded）；

  6. any other sever diseases such as malignant tumor；

  7. the patients who attending other clinical study in late 3 months；

  8. pregnant or lactating women；

  9. the patients who have allergic constitution or are allergic to many drugs.

Study Design

Total Participants: 1042
Study Start date:
March 01, 2012
Estimated Completion Date:
June 30, 2015

Study Description

We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.

Connect with a study center

  • Jilin Province TCM Institute of Chinese Medicine

    Changchun, Jilin 130000
    China

    Site Not Available

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