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Clinical Study of Fuling Sini Decoction on Intervention of Septic Cardiomyopathy and Immune Paralysis

Registration number：

ITMCTR2100004753

Date of Last Refreshed on：

2021-04-19

Date of Registration：

2021-04-19

Registration Status：

Prospective registration

Public title：

Clinical Study of Fuling Sini Decoction on Intervention of Septic Cardiomyopathy and Immune Paralysis

English Acronym：

Scientific title：

Clinical Study of Fuling Sini Decoction on Intervention of Septic Cardiomyopathy and Immune Paralysis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100045549 ; ChiMCTR2100004753

Applicant：

Wang Ping

Study leader：

Wang Ping

Applicant telephone：

+86 13530289607

Study leader's telephone：

+86 13530289607

Applicant Fax：

Study leader's fax：

Applicant E-mail：

734020972@qq.com

Study leader's E-mail：

734020972@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

1 Dayun Road, Tiyu New City, Longgang District, Shenzhen, Guangdong

Study leader's address：

1 Dayun Road, Tiyu New City, Longgang District, Shenzhen, Guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)

Approved by ethic committee：

Approved No. of ethic committee：

SZLDH2020LSYM-013

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine

Date of approved by ethic committee：

2020/4/27 0:00:00

Contact Name of the ethic committee：

Hu Shiping

Contact Address of the ethic committee：

1 Dayun Road, Tiyu New City, Longgang District, Shenzhen, Guangdong

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)

Primary sponsor's address：

1 Dayun Road, Tiyu New City, Longgang District, Shenzhen, Guangdong

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Shenzhen

Institution
hospital：

Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)

Address：

1 Dayun Road, Tiyu New City, Longgang District

Source(s) of funding：

Scientific Research Project of Guangdong Provincial Bureau of Traditional Chinese Medicine

Target disease：

Septic Cardiomyopathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

This study aims to investigate whether Fuling Sini Decoction promotes myocardial repair by improving the immune paralysis of septic cardiomyopathy, so as to partially clarify the therapeutic mechanism of Fuling Sini Decoction in the treatment of septic cardiomyopathy.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1.Meet the diagnostic criteria of septic cardiomyopathy; 2.TCM syndrome differentiation meets the diagnostic criteria of cardiopulmonary qi deficiency and (or) heart and kidney yang deficiency and (or) yang deficiency and water flooding syndrome; 3.Aged between 18-80 years old; 4.Patients Or family members signed an informed consent form.

Exclusion criteria：

1.ICU hospitalization time is less than 3 days; 2.History of serious underlying heart diseases; 3.Patients with advanced tumor; 4.Patients with primary liver, kidney, and blood system with serious underlying diseases; 5.Contraindications to enteral nutrition; 6.Patients with immunodeficiency; 7.Intestinal Nutritional contraindications; 8.Pregnant and lactating women.

Study execute time：

From 2020-08-01

To      2022-10-31

Recruiting time：

From 2021-06-01

To      2022-06-30

Interventions：

30

Group：

Therapy group

Sample size：

Intervention：

Traditional western medicine combined with Fuling Sini Decoction

Intervention code：

30

Group：

Control group

Sample size：

Intervention：

Traditional western medicine

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Beijing University of Chinese Medicine Shenzhen Hospital (Longgang)

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Multiple organ dysfunction score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum inflammatory cytokines (interleukin-6, procalcitonin, c-reactive protein)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Acute physiology and chronic health score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immunological indicators (peripheral blood HLA-DR, CD4+T lymphocytes, CD8+T lymphocytes, natural killer cells, regulatory T cells, helper T cells 17, interleukin-10, immunoglobulin IgG, IgM)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

ICU hospital stay

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

28-day mortality

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum markers of myocardial injury (cardiac troponin, creatine kinase isoenzyme, cardiac fatty acid binding protein, amino-terminal brain natriuretic peptide precursor)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Others

Note：

Recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

An independent researcher determines a random sequence from a computer-generated random number table and groups it into a random distirbution table.

Blinding：

Not stated

IPD sharing：

Yes

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

After the trial has finished, Chinese Clinical Trial Registry, check on the internet.

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

CRF Excel SPSS.

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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