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A randomized controlled clinical Trial for Qingre Huayu Formula on left ventricular remodeling in patients with ST segment elevation myocardial infarction

A randomized controlled clinical Trial for Qingre Huayu Formula on left ventricular remodeling in patients with ST segment elevation myocardial infarction

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003834
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST segment elevation myocardial infarction

Interventions

Sponsors

Shuguang Hospital of Shanghai University of Traditional Chinese
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) patient aged 18 and 85 years old; (2) It conforms to the diagnosis of acute myocardial infarction in Western medicine, and is diagnosed as "death heartache" by Traditional Chinese medicine. The syndrome belongs to the syndrome of "blood stasis and obstruction"; (3) Patients with single-vessel, double-vessel or three-vessel coronary lesions diagnosed by emergency coronary angiography and and PCI with onset time less than 6 hours.

Exclusion criteria

Exclusion criteria: 1. Patients who did not undergo coronary angiography +PCI; 2. Pregnant women and lactating women; 3. Chest pain caused by other heart diseases, severe cardiac neurosis, menopausal syndromes, hyperthyroidism, cervical spondylosis, biliary disease, stomach and esophageal reflux, etc.; 4. Patients with severe heart and lung dysfunction and severe arrhythmia; 5. Patients with multiple organs such as heart, liver, brain and kidney, as well as hematopoietic system and other serious primary diseases, malignant tumors, or mental diseases; 6. Patients who are known to be allergic to such drugs and have a severe allergic constitution; 7. Recent (within 1 month) major trauma or surgical history, etc.

Design outcomes

Primary

MeasureTime frame
echocardiography (LVDd, LVSd, IVSd, LVpWd, LVEF, LVMI, LVRI);lymphocyte (Th1, Th2);inflammatory factor (IL-6, IL-17, IL-10, TGF-beta etc.);chemokine receptor (CXCR1-4\CCR-7 etc.);chemotactic factor (CCL1-5, 11 etc.);

Secondary

MeasureTime frame
Blood routine examination, hypersensitive CRP, SOD, BNP, TNI.;Blood routine and stool routine;TCM symptom improvement score;Liver function (ALT, AST, TBIL, ALP, GT), renal function (BUN, Cr, urinary microalbumin), urinary routine and urinary sediment microscopic examination, creatine kinase CK;Score of TCM syndrome of Heat and Phlegm-Blood Stasis ;Adverse events and adverse reactions shall be recorded at any time;

Countries

China

Contacts

Public ContactWANG Xiao-long

Shuguang Hospital of Shanghai University of Traditional Chinese

wxlqy0214@163.com+86 13501991450

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026