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Study on Key Technology of Zhilong Huoxue Tongyu Capsule in Prevention and Treatment of Hypertensive Myocardial Fibrosis

Study on Key Technology of Zhilong Huoxue Tongyu Capsule in Prevention and Treatment of Hypertensive Myocardial Fibrosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070345
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

hypertensive heart disease

Interventions

experimental group:Taking Zhilong Huoxue Tongyu Capsule 1.2 g for 14 days
Control group:Placebo capsules 1.2g orally for 14 days in addition to standard treatment
placebo capsules have the same appearance and odor as Zhilong capsules

Sponsors

Southwest Medical University Affiliated Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. meet the clinical diagnostic criteria for hypertensive heart disease in the 2018 European Society of Hypertension and European Society of Cardiology Guidelines for the Management of Hypertension. (history of hypertension; presence of symptoms of heart failure; cardiac enlargement visible on ECG, echocardiogram and chest X-ray) 2. between the ages of 18 and 75 years (excluding 18 and 75 years) 3. Patients were compliant and clearly understood the trial, voluntarily participated in the experimental study, and signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Erythrocyte pressure product 10 times normal) 4. Known severe renal impairment (eGFR 120 beats/min) 6. Severe aortic stenosis or mitral stenosis with known acute myocarditis, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, constrictive pericarditis or tamponade, etc; 7. Severe aortic insufficiency or severe mitral regurgitation, acute phase of atherosclerotic coronary heart disease requiring surgery or percutaneous intervention; 8. Dyspnea caused by an apparent non-cardiac cause, such as acute or chronic respiratory disease or infection; 9. Patients who have received any organ transplant or are currently undergoing an upcoming organ transplant (i.e., patients who are not excluded from the transplant waiting list) 10. Current (including within 2 hours prior to screening) or planned mechanical circulatory support (tracheal intubation for mechanical ventilation; intra-aortic balloon pump or any ventricular assist device; hemofiltration or dialysis) 11. Who have used the trial drug in the 3 months prior to screening or trial, or who have participated in another clinical study within 30 days prior to treatment 12. Those who are unable to follow medical advice or complete follow-up treatment or follow up procedures 13. Pregnant or nursing women or those who are planning to have children within 3 months of discontinuation of the drug women of childbearing potential, i.e., all women who are physiologically capable of becoming pregnant unless they are using an effective method of contraception during study treatment) 14. Persons with a known history of hypersensitivity to vermifugalong blood circulation and blood stasis capsules; 15. Patients with psychiatric disorders, severe depression, alcohol dependence, history of drug abuse, patients with exually transmitted infectious diseases (syphilis, acromegaly, etc.) 16. Patients with malignant tumors; 17. Patients who, in the judgment of the investigator, are unable to complete or are unfit to participate in this study 18. Those who refuse or cannot sign informed consent.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;

Secondary

MeasureTime frame
NLRP3mRNA;Left ventricular ejection fraction;Left ventricular short axis shortening rate;Ventricular septal thickness;Left ventricular end-diastolic internal diameter;Left ventricular end-systolic internal diameter;Left ventricular posterior wall thickness;Systolic blood pressure;Diastolic blood pressure;NYHA Heart Function Classification;TCM evidence score;60-day readmission rate for cardiovascular problems;60-day cardiovascular mortality;60-day incidence of major cardiovascular adverse events;Minnesota Heart Failure Quality of Life Scale;

Countries

China

Contacts

Public ContactYang Sijin

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

ysjimn@sina.com+86 13608286028

Outcome results

None listed

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