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The effect and mechanisms of Dachaihu Decoction on sepsis-induced liver injury based on the theory of gut-liver axis

Registration number：

ITMCTR2025000095

Date of Last Refreshed on：

2025-01-13

Date of Registration：

2025-01-13

Registration Status：

Retrospective registration

Public title：

The effect and mechanisms of Dachaihu Decoction on sepsis-induced liver injury based on the theory of gut-liver axis

English Acronym：

Scientific title：

The effect and mechanisms of Dachaihu Decoction on sepsis-induced liver injury based on the theory of gut-liver axis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yang Zhen

Study leader：

He Mingfeng

Applicant telephone：

15572780546

Study leader's telephone：

13802634839

Applicant Fax：

Study leader's fax：

Applicant E-mail：

20222120232@stu.gzucm.edu.cn

Study leader's E-mail：

he-mingfeng@foxmail.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 6 Qinren Road Zumiao Street Chancheng District Foshan City Guangdong Province China

Study leader's address：

No. 6 Qinren Road Zumiao Street Chancheng District Foshan City Guangdong Province China

Applicant postcode：

510006

Study leader's postcode：

510006

Applicant's institution：

Foshan Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY【2024】024

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Foshan Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/1/12 0:00:00

Contact Name of the ethic committee：

Zhang Bin

Contact Address of the ethic committee：

No. 6 Qinren Road Zumiao Street Chancheng District Foshan City Guangdong Province China

Contact phone of the ethic committee：

15572780546

Contact email of the ethic committee：

1510498641@qq.com

Primary sponsor：

Foshan Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No. 6 Qinren Road Chancheng District Foshan City Guangdong Province

Secondary sponsor：

Country：

China

Province：

Guangdong Province

City：

Foshan City

Institution
hospital：

Foshan Hospital of Traditional Chinese Medicine

Address：

No 6 Qinren Road, Chancheng District, Foshan City, Guangdong Province

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

sepsis-induced liver injury

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To evaluate the clinical efficacy of Dachaihu Decoction in the treatment of sepsis-induced liver injury.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(i) Meet the diagnostic criteria of sepsis; (ii) Meet the diagnosis of liver injury; (iii) Meet the diagnostic criteria of Chinese medicine; (iv) Age ≥18 and ≤85; (v) Those who voluntarily or their family members agreed to sign the informed consent.

Exclusion criteria：

① Patients with abnormal liver function not caused by sepsis; ② Patients with underlying liver diseases including viral hepatitis liver abscess autoimmune liver disease cirrhosis hepatocellular carcinoma; ③ Patients with previous history of allergic reaction to traditional Chinese medicines; ④ Patients who do not have the conditions for enteral feeding; ⑤ Patients during pregnancy or lactation.

Study execute time：

From 2024-01-12

To      2025-01-11

Recruiting time：

From 2024-01-12

To      2025-01-11

Interventions：

35

Group：

Control group

Sample size：

Intervention：

Western medicine standard treatment + equal volume boiling water at room temperature

Intervention code：

35

Group：

Treatment group

Sample size：

Intervention：

Treatment group was given standard dose of Dachaihu decoction for adults

Intervention code：

Total sample size ： 70

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong Province

City：

Foshan City

Institution/hospital：

Foshan Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

alkaline phosphatase, ALP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

D- Dimer

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Aspartate transaminase, AST

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Duration of mechanical ventilation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

NEU%

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Activated partial thromboplastin time, APTT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Creatinine, Cr

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

C--reactive protein, CRP

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

28-day survival status

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Indicators of the efficacy of Chinese medicine signs and symptoms

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Platelet, PLT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood urea nitrogen, BUN

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Albumin, ALB

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

neutrophilicgranulocyte, NEU

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Total bilirubin, TBil

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

SOFA score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Length of ICU stay

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fibrinogen, FIB

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

White blood cell, WBC

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Alanine transaminase, ALT

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Indicators of the efficacy of Chinese medicine signs and symptoms

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

APACHE II score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

UMA

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

γ-glutamyl transpeptidase, γ-GT

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Procalcitonin, PCT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Prothrombin Time, PT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
120
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Patients with septic liver injury who met the exclusion criteria of this study were randomly selected into the group and SPSS 29.0 statistical software was used to generate random numbers and a total of 70 patients were selected into the group. SPSS 29.0 statistical software was used to make a random number table and the enrolled patients were randomly divided into the treatment group and the control group. The number number and group of the enrolled patients were written on the random allocation card and the number was compiled on the cowhide envelope. The random number and group of the subjects were determined according to their admission sequence.

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：

All the data of the subjects during the study will be recorded into the computer for confidential storage and analysis. If necessary the records may be reviewed by the relevant institutions to confirm the truth accuracy and completeness of the data. The data obtained from the study may also be published in academic journals but the names of the subjects will not be published and the privacy of the subjects will be kept confidential.

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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