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Multicenter, randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of salvia tablets for intervention in postoperative angina pectoris in PCI

Multicenter, randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of salvia tablets for intervention in postoperative angina pectoris in PCI

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005650
Enrollment
Unknown
Registered
2021-06-20
Start date
2021-08-01
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

Angina Pectoris of Coronary Heart Disease

Interventions

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with angina pectoris within one year after PCI, and patients with angina pectoris symptoms; 2. Those who meet the standard of TCM syndrome differentiation of blood stasis syndrome; 3. The patient aged 18-75 years, and the gender is not limited; 4. The patient gave informed consent, with good compliance, and cooperated with follow-up follow-up and re-examination.

Exclusion criteria

Exclusion criteria: 1. Patients requiring vascular reconstruction, including myocardial infarction, left ventricular insufficiency, multivessel disease and/or massive myocardial ischemia (ischemic area > 10%), left main disease; 2. Patients with chronic refractory angina; 3. Patients with chronic kidney disease combined with severe heart, lung, liver and other vital organ dysfunction; severe primary disease, such as hematopoietic system and/or severe heart, lung, liver and other vital organ dysfunction; 4. Patients with severe uncontrolled hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg); 5. Severe arrhythmias (ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block, cardiac arrest, severe sinus tachycardia and bradycardia, sick sinus syndrome, reentrant supraventricular tachycardia, arrhythmias leading to hemodynamic changes); 6. Allergic constitution, or those who are allergic to multiple drugs and foods, or those who are known to be allergic to the ingredients of the drug; 7. Patients participating in other clinical trials or taking other proprietary Chinese medicines within one month; 8. Pregnant or lactating women; 9. Patients with mental, psychological and other problems that do not match the completion of the study.

Design outcomes

Primary

MeasureTime frame
Angina pectoris scale;

Secondary

MeasureTime frame
Tumor necrosis factor alpha;Interleukin 6;Total cholesterol;High-sensitivity C-reactive protein;High density lipoprotein;Fasting insulin;Triglycerides;Fasting blood sugar;Blood clotting function;Low-density lipoprotein;Blood viscosity;Thromboelastogram;

Countries

China

Contacts

Public ContactFu Deyu

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

fdy65@126.com+86 13801833089

Outcome results

None listed

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