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Clinical study of Zhenwu Decoction combined with enhanced external counterpulsation in treating chronic heart failure with heart-kidney Yang deficiency type

Registration number：

ITMCTR2024000411

Date of Last Refreshed on：

2024-09-11

Date of Registration：

2024-09-11

Registration Status：

Prospective registration

Public title：

Clinical study of Zhenwu Decoction combined with enhanced external counterpulsation in treating chronic heart failure with heart-kidney Yang deficiency type

English Acronym：

Scientific title：

Clinical study of Zhenwu Decoction combined with enhanced external counterpulsation in treating chronic heart failure with heart-kidney Yang deficiency type

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jue SHI

Study leader：

Jin SHU

Applicant telephone：

18201893059

Study leader's telephone：

18918255966

Applicant Fax：

Study leader's fax：

Applicant E-mail：

67121565@qq.com

Study leader's E-mail：

shu_jin@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Rehabilitation platform 6th floor Clinic 4500 Gonghe Xin Road Jing 'an District Shanghai

Study leader's address：

Rehabilitation platform 6th floor Clinic 4500 Gonghe Xin Road Jing 'an District Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shibei Hospital ofShanghai

Approved by ethic committee：

Approved No. of ethic committee：

YL-20240903-32

Approved file of Ethical Committee：

View

Name of the ethic committee：

The Medical ethics committee of Shibei Hospital of Jing'an District Shanghai

Date of approved by ethic committee：

2024/9/4 0:00:00

Contact Name of the ethic committee：

Hua YANG

Contact Address of the ethic committee：

The Science and education section of Rehabilitation platform 6th floor Clinic 4500 Gonghe Xin Road Jing 'an District Shanghai

Contact phone of the ethic committee：

021-36538658

Contact email of the ethic committee：

shibeikejiao@163.com

Primary sponsor：

Shibei Hospital of Shanghai

Primary sponsor's address：

Shibei Hospital of Shanghai

Secondary sponsor：

Country：

CHINA

Province：

SHANGHAI

City：

SHANGHAI

Institution
hospital：

Shibei Hospital of Jing'an District Shanghai

Address：

4500 Gonghe Xin Road Jing 'an District Shanghai

Source(s) of funding：

Jingan District health research project fund and unit self-funding

Target disease：

Chronic heart failure

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

(1) Break through the limitations of the use of simple western anti-heart failure drugs recommended by the current guidelines. (2) Improving heart function and quality of life in patients with heart failure. (3) Previous studies have shown that Zhenwu Decoction has a certain effect on heart failure. Combined with enhanced external counterpulsation therapy in cardiac rehabilitation Zhenwu Decoction has expanded ideas for standardizing the treatment of chronic heart failure with integrated Chinese and Western medicine and improved the level of integrated Chinese and Western medicine in the treatment of chronic heart failure.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Diagnostic criteria of Western medicine: a history of coronary heart disease in the past while meeting the above diagnostic criteria for chronic heart failure. 2. TCM diagnostic criteria: According to the relevant content of Shanghai TCM Diagnosis and Treatment Routine (second edition) the main symptoms are: palpitation shortness of breath asthma feeling afraid of cold hands and feet not warm. Secondary symptoms: oliguria edema abdominal distension and loose stool pale gray. Tongue and pulse: the tongue is light and fat or has tooth marks and the pulse is heavy or late. The main disease must have 2 items the secondary disease has 2 items combined with the tongue and pulse the diagnosis can be established. 3. Age: 45 ~ 85 years old. 4. Grading of heart function: According to the New York Heart Association (NYHA) grading of heart function the heart function is grade II to III.

Exclusion criteria：

1. Patients with bronchial asthma chronic bronchitis pulmonary heart disease and chronic obstructive pulmonary disease. 2. Patients with unstable blood pressure control. 3. Patients with acute cardiac insufficiency. 4. Severe liver and kidney dysfunction and heart failure due to kidney liver and other important organ failure. 5. Patients with serious primary diseases such as endocrine system and hematopoietic system.（YNMT）·

Study execute time：

From 2022-10-01

To      2025-10-01

Recruiting time：

From 2024-10-01

To      2025-06-01

Interventions：

54

Group：

Zhenwu Tang Group

Sample size：

Intervention：

Oral drugs are based on ARB preparations aldosterone antagonists and beta-blockers with EECP treatment and Zhenwu Decoction

Intervention code：

54

Group：

Control group

Sample size：

Intervention：

Oral drugs are based on ARB preparations aldosterone antagonists and beta-blockers with EECP treatment

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

CHINA

Province：

SHANGHAI

City：

SHANGHAI

Institution/hospital：

Shibei Hospital of Jing'an District Shanghai

Level of the institution：

second-level hospital

Outcomes：

Outcome：

Blood routine examination

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

3/5000 electrolyte

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

PRO-BNP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

5/5000 echocardiography

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver and kidney function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

urinalysis

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

45
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomized double-blind grouping with a random sequence generated by the clinician using Python

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

no

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form and Electronic Data Capture

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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