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Clinical Study on secondary development of Qihong Capsule Hospital preparation

Clinical Study on secondary development of Qihong Capsule Hospital preparation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052399
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

chronic heart failure

Interventions

Test group :Qihong capsule
control group :Standard treatment of Western Medicine

Sponsors

Xinjiang Uygur Autonomous Region Institute of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for chronic heart failure, and have a history of chronic heart failure for more than 3 months or clinical symptoms of heart failure for more than 3 months; 2. Heart failure patients with TCM syndrome differentiation of Qi deficiency and blood stasis; 3. Age 30-80 years old; 4. Left ventricular ejection fraction (LVEF) >= or = 450pg/ml; 5. NYHA cardiac function class II-III; 6. Those who received at least 2 weeks of standardized western medicine treatment and reached the optimal therapeutic dose; 7. Those who have not used traditional Chinese medicine for the treatment of heart failure within 2 weeks before enrollment; 8. Voluntarily participate in this clinical trial, understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who undergo coronary revascularization and cardiac resynchronization therapy within 12 weeks, or those who plan to undergo cardiac resynchronization therapy within 12 weeks; 2. Patients with severe primary diseases such as liver, kidney, hematopoietic system, tumor patients, severe neuroendocrine system diseases and mental illness; uncontrolled hypertension patients, systolic blood pressure >=180mmHg and/or diastolic blood pressure >=100mmHg; 3. Alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, and serum creatinine exceeded 2 times the upper limit of normal, and serum potassium was greater than 5.5 mmol/L; 4. Patients with acute myocarditis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, restrictive cardiomyopathy, large aneurysm, arterial dissection, congenital heart disease, severe malignant arrhythmia, significant hemodynamic changes and unrepaired heart valve disease ; 5. Severe peripheral arterial disease, acute exacerbation of chronic obstructive pulmonary disease, pulmonary vascular disease such as primary pulmonary hypertension or pulmonary hypertension due to autoimmune diseases; 6. Pregnant or planning to become pregnant and lactating women; 7. Those with allergies, or those who are known to be allergic to therapeutic drugs; 8. Participate in other drug clinical investigators within 1 month.

Design outcomes

Primary

MeasureTime frame
N-terminal natriuretic peptide precursor;6-minute walk test;

Countries

China

Contacts

Public ContactHe Yi

Xinjiang Uygur Autonomous Region Institute of traditional Chinese Medicine

313080415@qq.com+86 15099370293

Outcome results

None listed

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