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Multicenter, randomized, double-blind, placebo parallel control evaluation of Xin Yang and Xin Yin pills clinical research for the treatment of chronic heart failure

The special advantages of TCM from TCM strong province construction disease breakthrough project (chronic heart failure)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008358
Enrollment
Unknown
Registered
2016-04-26
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic heart failure

Interventions

Gas Yin deficiency and blood stasis water park group:Xin Yin pills
Gas Yin deficiency and blood stasis water stop the control group:Xin Yin pills simulation of medicine
Qi Yang deficiency and blood stasis water park group:Xin Yang pills
Qi Yang deficiency and blood stasis water stop the control group:Xin Yang pills simulation of medicine

Sponsors

The first affiliated hospital of guangzhou university of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. conforms to the diagnostic criteria of chronic congestive heart failure, cardiac function class II - IV (NYHA), left ventricular ejection fraction of 45% or less, the BNP acuity 200 pg/ml; 2. conform to the traditional Chinese medicine qi and Yin deficiency and blood stasis of water stop or qi Yang deficiency, blood stasis water stop syndrome differentiation standard; 3. aged 18 to 75 years old; 4. according to the 2014 China chronic heart failure diagnosis, and treatment guidelines, have accepted at least 2 weeks of fixed dose the optimal drug therapy of western medicine; 5. the original is Chinese traditional medicine to treat heart failure stop using medicine for more than 2 weeks. 6. sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. acute cardiac insufficiency; 2. accompanied by cardiac shock, or fatal arrhythmia, II above 0 II 0 type atrioventricular block (AVB), severe obstructive cardiomyopathy, valvular disease, constrictive pericarditis, cardiac tamponade, pulmonary embolism, patients with acute myocardial infarction, and there are other drugs for heart failure the efficacy and safety of the determination of disease; 3. merge serious lung, liver, kidney failure, severe primary diseases such as endocrine system, hematopoietic system; 4. because of digitalis drugs poisoning caused by heart failure symptoms worsen. 5. pregnancy or lactation; 6. merge with psychosis, or unwilling to partners; 7. four weeks in other test drug; 8. not suitable in the study which researchers say.

Design outcomes

Primary

MeasureTime frame
BNP;traditional Chinese medicine symptom;cardiac functional grading;EF;6 minutes walking distance;The quality of life score;

Countries

China

Contacts

Public ContactZhongqi Yang

The first affiliated hospital of guangzhou university of TCM

yang_zhongqi@163.com+86 13688867618

Outcome results

None listed

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