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Clinical efficacy evaluation of Guanxin Ning Tablets in the treatment of patients with coronary heart disease of qi deficiency and blood stasis type, qi stagnation and blood stasis type and cold coagulation and blood stasis type

Clinical efficacy evaluation of Guanxin Ning Tablets in the treatment of patients with coronary heart disease of qi deficiency and blood stasis type, qi stagnation and blood stasis type and cold coagulation and blood stasis type

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001764
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-09-18
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

coronary heart disease

Interventions

Qi deficiency and blood stasis type coronary heart disease group:Guanxinning tablet
Qi stagnation and blood stasis coronary heart disease group:Guanxinning tablet
Cold coagulation and blood stasis coronary heart disease group:Guanxinning tablet

Sponsors

Jiashan County Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18~75 years old, including 18 and 75 years old, both men and women; (2) Meet the diagnostic criteria for coronary heart disease in Western medicine; (3) The syndrome differentiation of traditional Chinese medicine is qi deficiency and blood stasis, qi stagnation and blood stasis, and each syndrome meets moderate and severe (the syndrome scores of qi deficiency, qi stagnation, cold coagulation and blood stasis are all 13~23 points); (4)Volunteer to participate in this study and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed by a witness and the informed consent form must be signed.

Exclusion criteria

Exclusion criteria: (1) Those who have a history of myocardial infarction, coronary angioplasty or coronary artery bypass grafting within 3 months; (2) Those who have arrhythmias (such as second- and third-degree atrioventricular block, atrial fibrillation, atrial flutter, sinus syndrome, pre-excitation syndrome, complete left bundle branch block, etc.) and are not suitable to participate in this trial, or those who have a built-in pacemaker or electrical cardioversion; (3) Patients with clinically significant valvular disease, congenital heart disease, pulmonary hypertension, chronic obstructive pulmonary disease, dissection aneurysm, hypertrophic cardiomyopathy, acute myocarditis, pericarditis; (4) New York College of Cardiology NYHA grade IV, or acute pulmonary edema, EF = 35% on echocardiography; (5) Mental abnormalities that cannot be cooperated, epilepsy, menopausal syndrome, hyperthyroidism, biliary heart syndrome, gastric and esophageal reflux, hiatal hernia, etc. Serious diseases (such as tumors, etc.) that affect the clinical investigator or affect survival in the opinion of the investigator; (6) Combined with poorly controlled hypertension (sitting systolic blood pressure =180mmHg, sitting diastolic blood pressure =110mmHg); (7) Combined with other clinical conditions that may lead to an increased risk of bleeding, such as a history of bleeding in important organs in the past six months (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), low platelet count, abnormal coagulation function, and oral anticoagulant therapy; (8) Patients with active liver disease, or with unexplained continuous elevation of serum aminotransferases, or any of the aspartate aminotransferase AST and alanine aminotransferase ALT at screening >2 times the upper limit of normal value), or patients who are assessed by the investigator to be unsuitable for this study; (9) Patients with abnormal renal function assessment and unsuitable for participation in this study assessed by the investigator; Cr or BUN> 1.5 times the upper limit of normal value; (10) Those who are allergic to the drug ingredients of Guanxinning tablets or have an allergic constitution; (11) Patients who have participated in other clinical trials in the past 1 month; (12) Pregnant or lactating women; (13)Patients who are considered by the investigator to have other factors that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine Syndrome Scoring;

Secondary

MeasureTime frame
Single-cell sequencing results;

Countries

CHINA

Contacts

Public ContactTang Wansheng

Jiashan County Hospital of Traditional Chinese Medicine

tangwansheng2008@126.com+86 159 6738 5240

Outcome results

None listed

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