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Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up |
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| Placebo group | Placebo Comparator | The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUSK pill | Drug | This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| the difference of HRR between the experimental group and the placebo group was significant | Definition of abnormal heart rate recovery: peak HR during exercise - HR one minute into recovery at the end of exercise is defined as abnormal heart rate recovery when HR one minute into recovery is less than 12 beats / min. | At the end of treatment (8 weeks (± 1 week)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HaiMing Shi, doctor | Contact | +8613901824859 | 13901824859@163.com | |
| Ying Shan, doctor | Contact | +8613402021699 | shanyingli@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| HaiMing Shi, doctor | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D003327 | Coronary Disease |
| D017566 | Microvascular Angina |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C008563 | musk |
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1:1 stratified block random grouping according to the center
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|
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| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |