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Study on clinical efficacy of combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir in the treatment of compensated patients with liver cirrhosis related to hepatitis B

Registration number：

ITMCTR2100005358

Date of Last Refreshed on：

2021-11-29

Date of Registration：

2021-11-29

Registration Status：

Prospective registration

Public title：

Study on clinical efficacy of combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir in the treatment of compensated patients with liver cirrhosis related to hepatitis B

English Acronym：

Scientific title：

Study on clinical efficacy of combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir in the treatment of compensated patients with liver cirrhosis related to hepatitis B

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100053815 ; ChiMCTR2100005358

Applicant：

Tong Li

Study leader：

Songqi He

Applicant telephone：

13703021713

Study leader's telephone：

13697499297

Applicant Fax：

Study leader's fax：

Applicant E-mail：

xuenight@126.com

Study leader's E-mail：

hesongqijz@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

TCM-Integrated Hospital of Southern Medical University,No.13,Shiliugang Road West,Haizhu District,Guangzhou,Guangdong Province

Study leader's address：

TCM-Integrated Hospital of Southern Medical University,No.13,Shiliugang Road West,Haizhu District,Guangzhou,Guangdong Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

TCM-Integrated Hospital of Southern Medical University

Approved by ethic committee：

Approved No. of ethic committee：

Approved file of Ethical Committee：

Name of the ethic committee：

Date of approved by ethic committee：

2013/8/26 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

TCM-Integrated Hospital of Southern Medical University

Primary sponsor's address：

TCM-Integrated Hospital of Southern Medical University,No.13,Shiliugang Road West,Haizhu District,Guangzhou,Guangdong Province

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

TCM-Integrated Hospital of Southern Medical University

Address：

TCM-Integrated Hospital of Southern Medical University,No.13,Shiliugang Road West,Haizhu District,Guangzhou,Guangdong Province

Source(s) of funding：

TCM-Integrated Hospital of Southern Medical University

Target disease：

compensation period for liver cirrhosis related to hepatitis B

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To explore and evaluate the effectiveness and safety of the treatment of compensation period for liver cirrhosis related to hepatitis B in the combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1)meet the western medical diagnostic criteria for the compensation period for liver cirrhosis related to hepatitis B; (2)meet the diagnostic criteria for Chinese medicine for Gan Dan Shi Re Jia Yu;(3)meet the antiviral standards for hepatitis B;(4)not use any antiviral drugs other than Entecavir within 3 months of diagnosis;(5)age 18-65 years old at the time of diagnosis, gender unlimited;(6)Informed consent and treatment and treatment-related laboratory examination, and can answer questions truthfully.

Exclusion criteria：

(1) Testing for sero HIV; (2) combining other viral liver diseases, non-alcoholic fatty hepatitis, explicit drug-damaging liver disease, self-free liver and other chronic liver diseases; (3) the combination of other chronic severe hepatitis, liver cirrhosis, liver cancer and other serious or terminal liver disease; (4) other diseases seriously affect their quality of life. If there are severe organ dysfunction and severe diabetes, liver and kidney syndrome, liver and lung syndrome or other severe trauma caused by liver disease;

Study execute time：

From 2021-06-01

To      2023-05-31

Recruiting time：

From 2021-12-01

To      2023-03-31

Interventions：

34

Group：

Control group

Sample size：

Intervention：

Entecavir

Intervention code：

34

Group：

Test group

Sample size：

Intervention：

combination therapy with Bie Jia Ruan Gan Jian Pi Fang and Entecavir

Intervention code：

Total sample size ： 68

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

TCM-Integrated Hospital of Southern Medical University

Level of the institution：

Grade III

Outcomes：

Outcome：

liver function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Symptom & Signs

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

serum indices of hepatic fibrosis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fibroscan

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

color Doppler ultrasound of liver, bile, pancreas and spleen

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

HBV marker

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

APRI score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

routine blood test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

kidney function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

FIB-4 score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

routine urine test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

HBV-DNA

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：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The grouping method of random number table generated by Excel is adopted.

Blinding：

IPD sharing：

Yes

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

N/A

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

The subject data on the case report form should be recorded in the subject code format and the subject can only be identified by the subject code or his/her initials. All experimental data will be organized, saved and uploaded by the data management personnel of the research group.

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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