Theraphy of Chinese Traditional Medicine Clinical Trial
Official title:
Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia With Conventional Therapy for Coronary Heart Disease Combined With Traditional Chinese Medicine :Design and Methods
This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect, namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM - Xinkeshu tablets.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | December 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. above 18 years old, 2. having coronary stenosis (> 70%) measured by coronary arteriography, 3. with medical history of myocardial infarction or revascularization procedures, 4. or with sufficient proof for having CHD. Exclusion Criteria: 1. patient age younger than 18, 2. clearly impaired cognitive function, 3. damage of functions of vital organs, 4. suicidal ideation, 5. mental diseases treated with selective serotonin reuptake inhibitor (SSRI) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anzhen Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Meiyan Liu |
China,
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* Note: There are 23 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Left ventricular ejection fraction | reduction of LVEF by 5% or more | up to 8 weeks | Yes |
| Primary | ventricular wall motion | Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole | up to 8 weeks | Yes |