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The Biological Basis Research of Qi-deficiency Syndrome based on ZangFu in TCM: A systematic clinical study to explore the biological basis of chronic heart failure with Qi-deficiency syndrome

The Biological Basis Research of Qi-deficiency Syndrome based on ZangFu in TCM: A systematic clinical study to explore the biological basis of chronic heart failure with Qi-deficiency syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017509
Enrollment
Unknown
Registered
2018-08-02
Start date
2018-08-06
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

chronic heart failure

Interventions

chronic heart failure:Qi-tonifying formula
Normal control:none

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 35-75 years old, male or female; 2. TCM diagnosis of Qi-deficiency syndrome or Qi-deficiency and Blood-stasis syndrome; 3. Meeting the diagnostic criteria of both chronic heart failures and coronary heart diseases; 4. Patients with class II-III of NYHA; 5. Left ventricular ejection fraction (LVEF) = 40%; 6. Volunteers participate with signed the Letter of Informed and Consent.

Exclusion criteria

Exclusion criteria: 1. Patients with one of the following conditions: acute coronary syndrome within 30 days; cardiogenic shock; second degree Morbiz II sinoatrial or atrioventricular block without pacemaker implantation therapy, uncontrolled malignant arrhythmias; dilated cardiomyopathy; hypertrophic obstructive cardiomyopathy; myocarditis; pulmonary embolism; severe valvular disease; stroke in recent 6 months; 2. Patients with severe liver and kidney function damage, with alanine aminotransferase> 3 times of the upper limit of normal, or serum creatinine> 265umol/L; 3. Patients with major systemic diseases combined such as the respiratory system, nervous system, and immune system, patients with malignant tumors or with severe trauma or infection; 4. Poorly controlled chronic diseases such as hypertension and diabetes; 5. Those who have complicated accompanying syndromes, including excess syndromes such as phlegm, coldness, and heat toxicity, as well as patients with obvious Yin-deficiency or Yang-deficiency; 6. Patients with allergic constitution; 7. Women who are pregnant, lactating, or have a pregnancy intention or positive pregnancy test (test urine HCG or blood HCG), or those who cannot take effective contraception during the study (effective contraception includes sterilization, IUD, oral contraceptives or the diaphragm method by the local law); 8. Patients who participated in other drug clinical trials in the past 1 month; 9. Patients with mental disorders, neurological impediments, or failure to express themselves or communicate; 10. Alcoholics, drug abusers and addicts.

Design outcomes

Primary

MeasureTime frame
The syndrome scorings of the Qi-deficiency;

Secondary

MeasureTime frame
LVEF;NT-BNP;

Countries

China

Contacts

Public ContactHao Xu

Xiyuan Hospital of China Academy of Chinese Medical Sciences

jiang_yuerong@163.com+86 18601081161

Outcome results

None listed

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