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Efficacy and safety of Xuefu Zhuyu Granules combined with Western medicine in the treatment of angina pectoris of coronary heart disease: A study protocol of a randomized, double-blind, placebo-controlled clinical trial

Efficacy and safety of Xuefu Zhuyu Granules combined with Western medicine in the treatment of angina pectoris of coronary heart disease: A study protocol of a randomized, double-blind, placebo-controlled clinical trial

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220906002
Enrollment
52
Registered
2022-09-06
Start date
2022-10-11
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Coronary heart disease is one of the most common chronic diseases worldwide[1]. According to statistics, 17.9 million people died of cardiovascular diseases worldwide in 2016, of which about 34% died of coronary heart disease[2-3]. Angina pectoris is the most important and common type[4]. It is a syndrome caused by acute myocardial ischemia and hypoxia[5]. Studies have shown that angina pectoris of coronary heart disease is not treated in time, about 30% of patients will develop myocardial infar

Interventions

patients will receive Western medicine treatment based on guideline recommendations. On this basis, they orally takes Xuefu Zhuyu Granules and are followed up for 24 weeks after 12 weeks of continuous
Experimental Other,Experimental Other
patients will receive Western medicine treatment and orally takes Xuefu Zhuyu Granules,patients will receive Western medicine treatment and orally takes Xuefu Zhuyu Granules mimic

Sponsors

Dong Liu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of coronary heart disease angina pectoris in traditional Chinese medicine and Western medicine, coronary angiography or coronary angiography showed at least one coronary artery stenosis and catheter stenosis at least 50%; (2) Aged at least 18 years old, and at least 70 years old; (3) Canadian Cardiovascular Society (CCS) classification of angina pectoris is grade I-III; (4) Angina pectoris attack frequency at least 2 times/week, and less than or equal to 6 times/day; (5) Patients agreed to join this study, and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone coronary artery bypass surgery; (2) Patients with other serious diseases (such as severe cardiopulmonary dysfunction, tumor, etc.) or ALT, AST or Cr reaching 1.5 times of the normal upper limit (3) Patients with other diseases that may increase the risk of bleeding (such as cerebral hemorrhage, upper gastrointestinal bleeding), the platelet count decreased, coagulation dysfunction, etc. (4) Pregnant, preparing for pregnancy or lactating women; (5) Patients are allergic to the use of drugs in the study; (6) Participated in or are participating in other clinical trials in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Cardiac function indexes: LVEDD, LVESD and LVEF will be measured by color doppler ultrasonic diagnostic apparatus 24 weeks Cardiac function indexes: LVEDD, LVESD and LVEF will be measured by color doppler ultrasonic diagnostic apparatus

Secondary

MeasureTime frame
Blood lipid levels: Fasting veins of the patients will be collected in the morning before and after treatment and during follow-up, and blood lipid index, including TC TG; 24 weeks LDL-C and HDL-C, were measured by an automatic biochemical analyzer

Countries

China

Contacts

Public ContactDong Liu

The People Hospital of DaZu

sdbiah@163.com18523807819

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026