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Observation on the Efficacy of Shenge Powder on the Patients of Chronic Heart Failure

Registration number：

ITMCTR2100005159

Date of Last Refreshed on：

2021-08-09

Date of Registration：

2021-08-09

Registration Status：

Prospective registration

Public title：

Observation on the Efficacy of Shenge Powder on the Patients of Chronic Heart Failure

English Acronym：

Scientific title：

Observation on the Efficacy of Shenge Powder on the Patients of Chronic Heart Failure

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100049790 ; ChiMCTR2100005159

Applicant：

+86 13918690782

Study leader：

Zhou Li

Applicant telephone：

13918690782

Study leader's telephone：

+86 13918690782

Applicant Fax：

Study leader's fax：

Applicant E-mail：

babyzhouli@hotmail.com

Study leader's E-mail：

babyzhouli@hotmail.com

Study leader's website(voluntary supply)：

上海市嘉定区南翔医院

Study leader's website
(voluntary supply)：

Applicant address：

495 Zhongren Road, Jiading District, Shanghai

Study leader's address：

495 Zhongren Road, Jiading District, Shanghai

Applicant postcode：

201802

Study leader's postcode：

201802

Applicant's institution：

Nanxiang Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2020年5号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Nanxiang Hospital

Date of approved by ethic committee：

2020/9/11 0:00:00

Contact Name of the ethic committee：

Li Haiyang

Contact Address of the ethic committee：

495 Zhongren Road, Jiading District, Shanghai

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Nanxiang Hospital

Primary sponsor's address：

495 Zhongren Road, Jiading District, Shanghai

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

Nanxiang Hospital

Address：

495 Zhongren Road, Jiading District

Country：

China

Province：

Shanghai

City：

Institution
hospital：

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

725 Wanping Road South, Xuhui District

Source(s) of funding：

Special Project of Integrated Traditional Chinese and Western Medicine in Shanghai（NO：ZHYY-ZXYJHZX-202012）

Target disease：

Chronic heart failure

Target disease code：

Study type：

Interventional study

Study design：

Case-Control study

Study phase：

Pilot clinical trial

Objectives of Study：

To observe the clinical advantage on the efficacy of Shenge Powder together with standard treatment on the patients of chronic heart failure, and the results will help us make a promotion in the field of the treatment of chronic heart failure based on integrated traditional Chinese and western medicine.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Western medicine diagnostic criteria: have a history of coronary heart disease, and meet the above-mentioned diagnostic criteria for chronic heart failure; 2. TCM diagnostic criteria: formulated with reference to the relevant content of "Shanghai Traditional Chinese Medicine Diseases and Syndrome Diagnosis and Treatment Routine" (Second Edition), namely main symptoms: palpitations, shortness of breath and fatigue, asthma with movement, conscious fear of cold, and low temperature of hands and feet. Secondary symptoms: oliguria and edema, abdominal distension, loose stools, and pale complexion. Tongue pulse: The tongue is fat or has tooth marks, and the pulse is thin or late. The main symptoms must have 2 items, and the secondary symptoms have 2 items. Combined with the tongue and pulse, the diagnosis can be established; 3. Age: 45 to 85 years old; 4. Cardiac function classification: according to the New York Heart Association (NYHA) cardiac function classification method, the cardiac function is II to III.

Exclusion criteria：

1. Those with bronchial asthma, chronic bronchitis, pulmonary heart disease, chronic obstructive pulmonary disease; 2. Those with unstable blood pressure control; 3. Patients with acute cardiac insufficiency; 4. Patients with severe liver and kidney dysfunction and heart failure due to failure of important organs such as kidney and liver; 5. Patients with serious primary diseases such as endocrine system and hematopoietic system; 6. Pregnant or lactating women; 7. Those with allergic constitution or history of allergies; 8. Patients with mental disorders and unwilling to cooperate; patients with poor compliance, and those who interrupt the treatment before the prescribed observation period cannot judge the curative effect.

Study execute time：

From 2021-08-16

To      2023-06-30

Recruiting time：

From 2021-08-16

To      2022-12-31

Interventions：

54

Group：

Treatment group

Sample size：

SG

Intervention：

Treatment with Shenge Powder on the basis of conventional Western medicine.

Intervention code：

54

Group：

Control group

Sample size：

xy

Intervention：

Treatment with conventional Western medicine only.

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Teritary A

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Nanxiang Hospital

Level of the institution：

Secondary A

Outcomes：

Outcome：

Blood chlorine

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Ion electrode method

Outcome：

High-sensitivity C-reactive protein

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Turbidimetric inhibition immunoassay

Outcome：

Brain natriuretic peptide

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment;Time of study end

Measure method：

ChemiLuminescenc

Outcome：

White blood cell

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Flow cytometry

Outcome：

Interleukin-6

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment;Time of study end

Measure method：

Enzyme-linked immunosorbent assay (ELISA)

Outcome：

Alanine aminotransferase

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Nicotinamide Adenine Dinucleotide method

Outcome：

Serum potassium

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Ion electrode method

Outcome：

Cystatin C

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Latex immunoturbidimetry

Outcome：

High-Sensitivity Troponin T

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Chemiluminescence

Outcome：

Homocysteine

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment;Time of study end

Measure method：

Outcome：

TCM symptom score

Type：

Primary indicator

Measure time point of outcome：

At enrollment; follow-up every four weeks; end of study

Measure method：

TCM symptom score sheet

Outcome：

Hemoglobin

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Sodium Lauryl Sulfate (SLS) method

Outcome：

Nuclear factor kappa-B

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Outcome：

Platelets

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Sheath flow DC detection method

Outcome：

Six minute walking test (6MWT)

Type：

Primary indicator

Measure time point of outcome：

At enrollment; follow-up every four weeks; end of study

Measure method：

Standard of 6MWT

Outcome：

Electrocardiogram

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Operating standard of ECG

Outcome：

Quality of life assessment

Type：

Secondary indicator

Measure time point of outcome：

At enrollment; follow-up every four weeks; end of study

Measure method：

Scale scoring standard

Outcome：

Urine Routine Test

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Dry chemistry method

Outcome：

TCM Syndrome Score

Type：

Secondary indicator

Measure time point of outcome：

At enrollment; follow-up every four weeks; end of study

Measure method：

TCM symptom score standard

Outcome：

Echocardiography

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Operating standard of echocardiography

Outcome：

NYHA functional classification

Type：

Primary indicator

Measure time point of outcome：

At enrollment; follow-up every four weeks; end of study

Measure method：

Standard of NYHA functional classification

Outcome：

Red blood cell

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Sheath flow DC detection method

Outcome：

Serum creatinine

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Creatinine Assay Kit by SAO method

Outcome：

Aspartate aminotransferase

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Nicotinamide Adenine Dinucleotide method

Outcome：

Total Bilirubin

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Diazonium salts method

Outcome：

Blood sodium

Type：

Adverse events

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Ion electrode method

Outcome：

Tumor necrosis factor-α(TNF-α)

Type：

Secondary indicator

Measure time point of outcome：

Time of entrollment; Time of study end

Measure method：

Enzyme-linked immunosorbent assay (ELISA)

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)：

Random number sequence in the computer and the stratified segmentation method were both adopted by Wei Zhou in the first-level blinding，and coin flip method was used by Changjiang Hu in the second-level blinding.

Blinding：

IPD sharing：

Yes

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

2023-06-30

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

Case Record Form

Data Managemen Committee：

Not yet

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

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