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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
| Second Affiliated Hospital of Bengbu Medical College | OTHER |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
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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 control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | The experimental group was treated with Shexiang Baoxin pill(MUSKARDIA) (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up |
|
| Placebo group | Placebo Comparator | The control group was given placebo( 4 capsules / day, 3 times / day)on the basis of conventional treatment until the end of follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shexiang Baoxin pill(MUSKARDIA) | Radiation | On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Seattle angina pectoris scale | Main evaluation indicators | 12 weeks ± 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of angina attacks per week | Secondary evaluation index | 12 weeks ± 1 week |
| Changes in total dosage of sublingual nitroglycerin buccal tablets | Secondary evaluation index |
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Inclusion Criteria:
Exclusion Criteria:
(Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)
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| Name | Affiliation | Role |
|---|---|---|
| Chun Liang | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40020628 | Derived | He Z, Li N, Zhang W, Meng X, Wang J, Gong L, Liu B, Zheng M, Shang Z, Xu J, Jiang P, Zhao Q, Xu B, Liang C. Efficacy and safety of Shexiang Baoxin Pill in patients with angina and non-obstructive coronary arteries: A multicenter, randomized, double-blind, placebo-controlled, phase Ⅳ clinical trial. Phytomedicine. 2025 Apr;139:156556. doi: 10.1016/j.phymed.2025.156556. Epub 2025 Feb 23. |
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| Zibo Municipal Hospital |
| OTHER |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
| Shanxi Cardiovascular Hospital | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Tangshan Central Hospital | OTHER |
| Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group | UNKNOWN |
| Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group | UNKNOWN |
| General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group | UNKNOWN |
1:1 stratified block random grouping according to the center
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|
| Placebo | Radiation | On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up. |
|
|
| 12 weeks ± 1 week |
| Changes of angina pectoris classification in CCS | Secondary evaluation index | 12 weeks ± 1 week |
| Incidence of major cardiovascular events (MACE) | Secondary evaluation index | 12 weeks ± 1 week |
| the incremental cost-effectiveness ratio (ICER) was used as the evaluation index | Pharmacoeconomic evaluation | 12 weeks ± 1 week |
| 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 |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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