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Clinical efficacy and safety study of Qiwei Fangji Huangqi Granules in the treatment of chronic heart failure patients

Clinical efficacy and safety study of Qiwei Fangji Huangqi Granules in the treatment of chronic heart failure patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000173
Enrollment
Unknown
Registered
2025-01-25
Start date
2023-12-14
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Chronic heart failure

Interventions

treatment group:On the basis of conventional treatment Qiwei Fangji Huangqi granules were given
control group:Conventional treatment (refer to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018)

Sponsors

Hangzhou Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of western medicine referred to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018" issued by the Chinese Society of Cardiology in 2018 which met the diagnostic criteria of chronic heart failure and HFmrEF and HFpEF patients; 2. TCM diagnosis conforms to the syndrome differentiation criteria of TCM chronic heart failure with qi deficiency and blood stasis combined with internal water and drink cessation; 3. NYHA class II-III; 4. Age between 18 and 80 years old both male and female; 5. Voluntarily accept the drug treatment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Poorly controlled hypertension defined as a resting systolic blood pressure of 180mmHg or higher or a diastolic blood pressure of 110mmHg or higher on two independent visits before randomization; (2) patients with acute coronary syndrome patients with revascularization within one month or patients with planned revascularization within one week patients with cardiogenic shock fatal arrhythmia myocarditis constrictive pericarditis pulmonary embolism etc. 3. Autoimmune diseases such as systemic lupus erythematosus giant-cell myocarditis; 4. Patients with serious diseases (such as malignant tumors) or mental disorders that affect their survival and whose condition is poorly controlled or drug users have not been abstinent; 5. Severe hepatic and renal dysfunction (alanine aminotransferase (ALT) =3 times the upper limit of normal creatinine (Cr) =3mg/dL); 6. Patients with known allergy to the study drug (including its prescription ingredients); 7. Those who plan to be pregnant or are pregnant or lactating or who cannot be guaranteed effective contraception during the trial period; 8. Patients enrolled in other clinical trials within the past 3 months; 9. Patients with ineligible factors were identified by the investigator.

Design outcomes

Primary

MeasureTime frame
6 minutes walk distance;

Secondary

MeasureTime frame
homocysteine (Hcy);creatine kinase (CK);Triglyceride (TG);Interleukin-6 (IL-6);Creatine Kinase Isoenzyme (CK-MB);Left ventricular ejection fraction (LVEF);NYHA Classification;high density lipoprotein cholesterol (HDL-C);Interventricular septal thickness (IVSd);Left ventricular end-diastolic Diameter (LVEDD);Diuretic use;C-reactive protein (CRP);Rehospitalization for heart failure;Left ventricular posterior wall Thickness (LVPWd);The average intake and output of 24 hours during hospitalization;N-terminal B natriuretic peptide precursor;Apolipoprotein A1;3 6 months of major adverse cardiovascular events (MACE) events (including cardiovascular death non-fatal myocardial infarction (new onset myocardial infarction));Apolipoprotein B;low density lipoprotein cholesterin (LDL-C);Quality of Life Scale (Kansas City Cardiomyopathy Quality of Life Scale (KCCQ));Total cholesterol (TC);Lee's heart failure scale;Other biochemical indices;lactic dehydrogenase (LDH);TCM syndrome scoring scale;

Countries

China

Contacts

Public ContactChen Tielong

Hangzhou Traditional Chinese Medicine Hospital

ctlppp@163.com+86 189 5807 3605

Outcome results

None listed

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