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A randomized, double-blind, placebo-controlled, multi-center clinical study of Suxiao Jiuxin pills in patients with coronary heart disease nitrate intolerance

A randomized, double-blind, placebo-controlled, multi-center clinical study of Suxiao Jiuxin pills in patients with coronary heart disease nitrate intolerance

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050066
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-08-15
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

coronary artery disease

Interventions

Sponsors

The Affiliated Hospital of Shandong University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for chronic stable angina pectoris. 2. CCS angina pectoris grades I to III. 3. Aged 30 to 70 years. 4. Those who are intolerant to nitrates. 5. The subjects voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute myocardial infarction, unstable angina pectoris, stable angina pectoris with exertion IV and other heart diseases; 2. Combined with poorly controlled hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), use of pacemaker and history of cerebrovascular disease within 1 year ; 3. History or evidence of any of the following diseases during the screening period: severe cardiovascular and cerebrovascular diseases; active, recurrent digestive system ulcers or other diseases with bleeding risk; other serious diseases of the digestive system; combined with malignant tumors, hematological diseases or other serious or progressive diseases; combined with other mental diseases and unable to cooperate or unwilling to cooperate; 4. Any one of the laboratory test indicators before screening meets the following criteria: admission liver and kidney function prompts: ALT, AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value (Refer to the normal range of laboratory tests in the research center); other clinically significant laboratory tests are abnormal, and the investigators judge that they are not suitable for inclusion; 5. Suspect or have a history of alcohol or drug abuse; 6. Pregnant, lactating patients or those who are planning to become pregnant in the near future and who are unwilling to use contraceptive measures; 7. Patients who have participated in clinical trials of other drugs within 3 months before enrollment; 8. The researchers believe that patients should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Electrocardiogram;Changes of main symptoms of TCM;Blood stasis syndrome score;Seattle angina questionnaire;Patient-reported clinical outcome scale for coronary heart disease and angina pectoris;

Countries

China

Contacts

Public ContactLi Yunlun

The Affiliated Hospital of Shandong University of TCM

li.yunlun@163.com+86 531 68616759

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026