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Effect of Yangxinshumai Granule on Chronic Stable Angina Pectoris by Lipidomics: A Multicenter Randomized Placebo-Controlled Trial

Effect of Yangxinshumai Granule on Chronic Stable Angina Pectoris by Lipidomics: A Multicenter Randomized Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005419
Enrollment
Unknown
Registered
2021-12-17
Start date
2022-02-01
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

Chronic Stable Angina Pectoris

Interventions

Placebo Comparator Group:standard western medicine treatment + Yangxinshumai granules placebo

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Subject aged between 35 and 80 years old, unrestricted gender for male or female. 2.Subject's coronary CT or coronary angiography confirmed that at least one major branch of the coronary artery had stenosis at least 50%. 3.Subject has angina pectoris for more than 3 months, at least twice a week on baseline, and there was no significant change in the frequency, severity, nature, and inducing and relieving factors of angina pectoris at baseline. 4.Subject has deficiency of both Qi and Yin in TCM syndrome. 5.Subject voluntarily participates in the trial and signs informed consent.

Exclusion criteria

Exclusion criteria: 1.Subject plans to undergo Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) in the near future. 2.Subject has previous myocardial infarction. 3.Subject has severe cardiovascular disease (including: refractory heart failure, cardiogenic shock, valvular heart disease, severe arrhythmia). 4.Subject has atrial fibrillation. 5.Subject has primary cardiomyopathy. 6.Subject has severe respiratory disease. 7.Subject has poor blood pressure control (systolic blood pressure at least 180mmHg or diastolic blood pressure at least 110mmHg). 8.Subject's fasting blood glucose > 11.1mmol/L. 9.Subject has other serious primary diseases that cannot be effectively controlled, such as severe liver and kidney diseases, malignant tumors, pernicious anemia, etc.. 10.Subject with pregnancy or lactating. 11.Subject has taken Chinese medicines or Chinese patent medicines that have the effect of treating coronary heart disease within one months before enrollment. 12.Subject currently participates in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
frequency of angina pectoris;

Secondary

MeasureTime frame
lipid profile;time-domain parameters of heart rate variability (HRV);traditional Chinese medicine syndrome scores;nitroglycerin usage;seattle angina pectoris scale;

Countries

China

Contacts

Public ContactMing Liu
liuming@njucm.edu.cn13815885859

Outcome results

None listed

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