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Randomized double-blind controlled multicentre clinical study of Wendan Decoction in treating phlegm turbid syndrome of unstable angina pectoris of coronary heart disease

Randomized double-blind controlled multicentre clinical study of Wendan Decoction in treating phlegm turbid syndrome of unstable angina pectoris of coronary heart disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001869
Enrollment
Unknown
Registered
2025-09-28
Start date
2024-11-11
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Unstable angina pectoris of coronary heart disease

Interventions

Treatment group:Wendan Decoction granules
Simulation group:Wendan Decoction simulation granule

Sponsors

Nanjing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: It meets the diagnostic criteria of coronary heart disease in Western medicine. Coronary angiography/coronary CTA findings of at least one subepicardial coronary artery diameter stenosis greater than 50% or a clear history of myocardial infarction with a resting ECG showing previous myocardial infarction; Or have previously undergone revascularization therapy. It meets the diagnostic criteria of Western medicine UA(initial fatigue angina worsening angina spontaneous angina) and belongs to medium risk and low risk. It is in line with the diagnostic criteria of TCM chest numbness and pain disease. It meets the diagnostic standard of TCM syndrome of "phlegm turbidness syndrome" formulated in this research. Age =18 =75 years old; No gender limitation. Patients who do not receive PCI or CABG revascularization for the time being. Patients voluntarily participate in this clinical study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: After examination it was confirmed that coronary heart disease acute myocardial infarction unstable angina pectoris were high-risk patients in risk stratification and chest pain caused by other heart diseases cardiac neurosis menopausal syndrome and cervical spondylosis. Complicated with severe cardiopulmonary insufficiency severe arrhythmia liver kidney hematopoietic system and other serious primary diseases mental patients. Pregnant or lactating women. Allergic to this medicine. Patients who intend to undergo immediate PCI or CABG revascularization.

Design outcomes

Primary

MeasureTime frame
Curative effect of angina pectoris symptoms;Cessation rate of nitroglycerin;Serum Cardiac Troponin I;The number of cases where the condition progresses to acute myocardial infarction and requires urgent percutaneous coronary intervention or coronary artery bypass grafting.;

Secondary

MeasureTime frame
Electrocardiogram changes;Integral change and curative effect of TCM syndromes;Alpha-1 antitrypsin, apolipoprotein A1, apolipoprotein B, and apolipoprotein A1, apolipoprotein B protein expression.;Serum total cholesterol, low-density lipoprotein cholesterol, triglycerides (TG);Matrix metalloproteinase-9, Interleukin-6, LL-37 cathelicidin-derived antimicrobial peptide, Myeloperoxidase, Lipoprotein-associated phospholipase A2;

Countries

China

Contacts

Public ContactNing Gu

Nanjing Hospital of Traditional Chinese Medicine

jsguning@163.com18951755033

Outcome results

None listed

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