Clinical study of Xinbao pill in the treatment of chronic heart failure

A multicenter, randomized, double-blind, placebo-controlled clinical trial of Xinbao pill in the treatment of chronic heart failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17011876

Enrollment

Unknown

Registered

2017-07-05

Start date

2017-09-01

Completion date

Unknown

Last updated

2017-07-10

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

Conditions

Chronic Heart Failure(CHF)

Interventions

experimental group:Xinbao pill

control group:placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 80 years old; 2. Patients who meet the chronic heart failure diagnosis creteria, and have a history of chronic heart failure for more than 3 months, or clinical symptoms of heart failure for more than 3 months; 3. LVEF was less than 50%; 4. NYHA cardiac function classification II to III (hemodynamic stability, and without intravenous administration); 5. The serum NT-proBNP = 450pg/ml; 6. received the standard treatment at least 2 weeks; 7. To be able to and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing cardiac resynchronization therapy, or who will undergoing coronary revascularization or cardiac resynchronization therapy within 12 weeks; 2. combined with liver, kidney, hematopoietic system and other serious diseases. liver transaminase or alkaline phosphatase were 1.5 times the normal value, Cr>2mg/dl (194.5umol/L), potassium>5.5mmol/L; 3. combined with left ventricular outflow tract obstruction, myocarditis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, aortic aneurysm, aortic dissection, congenital heart disease, and significant hemodynamic changes in patients with silent valvular heart disease; 4. The patients with hypertension without control, SBP=180/mmHg and/or DBP=110mmHg; 5. during pregnancy and lactation women; 6. allergic to medicine of this trial; 7. the patients with glaucoma; 8. involved in any clinical trial in recent 1 month; 9. any other person.was not fit for this trial judged by researchers.

Design outcomes

Primary

Measure	Time frame
NT-proBNP;	—

Secondary

Measure	Time frame
primary end point event;LVEF;LVED;NYHA;6MWT;Minnesota quality of life scale;	—

Countries

China

Contacts

Public ContactDing Banghan

Guangdong Provincial Hospital of Chinese Medicine

banghanding@139.com+86 13682238225

Outcome results

None listed

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