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Integrated Traditional Chinese and Clinical Medicine for Chronic Hepatitis B and Its Complication

Primary Purpose

Hepatic Encephalopathy, Cirrhosis, Liver, Portosystemic Shunt

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
traditional Chinese medicine1 and traditional Chinese medicine 2
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TIPS treatment criteria in line with the 2017 edition of the "Expert Consensus on Transjugular Intrahepatic Portosystemic Shunt" were selected to include patients with hepatitis B cirrhosis and Child-pugh grade A and B after TIPS surgery.
  • Patients with liver cirrhosis, portal hypertension, bleeding from esophagus and gastric varices; refractory pleural and ascites due to liver cirrhosis; incomplete portal vein/localized thrombosis in liver cirrhosis or primary and secondary prevention of cirrhosis, portal hypertension, esophagus and gastric varices bleeding.

Exclusion Criteria:

  • Severe blood coagulation disorder (PTA≤20%) or platelets lower than 30×109/L;
  • Child-pugh classification of liver function C;
  • Those with respiratory and circulatory dysfunction;
  • Those whose systemic or focal infections have not been effectively controlled;
  • Patients with moderate to severe malnutrition;
  • Extensive primary or metastatic liver malignant tumors;
  • Those who are highly allergic to the products and drugs used in the treatment process.

Sites / Locations

  • he First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

group 1

group 2

group 3

group 4

Arm Description

traditional chinese medicine 1 and traditional chinese medicine 2 simulant

traditional chinese medicine 1 simulant and traditional chinese medicine 2

traditional chinese medicine 1 and traditional chinese medicine 2

traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant

Outcomes

Primary Outcome Measures

The incidence of hepatic encephalopathy
The incidence of hepatic encephalopathy after 12 weeks of treatment.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2021
Last Updated
November 16, 2021
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05128305
Brief Title
Integrated Traditional Chinese and Clinical Medicine for Chronic Hepatitis B and Its Complication
Official Title
Shandong Provincial Integrated Traditional Chinese and Clinical Medicine(Chronic Hepatitis B and Its Complication) Prevention and Treatment Project
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a very effective treatment. However, due to the severe complications such as hepatic encephalopathy after TIPS, the clinical application of TIPS is limited. Literature studies have shown that the incidence of encephalopathy after TIPS is about 35%. TIPS reduces the portal vena blood flow into the liver by establishing a new channel. But at the same time, the toxic substances from the gastrointestinal tract and other organs do not enter the liver to detoxify, and are more likely to enter the brain, leading to hepatic encephalopathy. Moreover, studies have found that the liver and the intestine originate from the same germ layer and are closely related to each other in anatomy and function. There are a large number of microorganisms living in the intestinal tract. Normally, the intestinal tract, as the first defense of the human body, can effectively prevent bacteria and their products from entering the bloodstream. In cirrhosis and portal hypertension, blood return disorder causes intestinal damage. A series of microbes and product endotoxins such as gram-negative bacteria will enter the blood through the injury, and the toxins in the peripheral blood will enter the brain and cause hepatic encephalopathy happened. The research team's early treatment plan with integrated traditional Chinese and Western medicine proved that it greatly reduced the incidence of hepatic encephalopathy after TIPS. And improve the clinical symptoms and signs of patients with liver cirrhosis, and improve the quality of life and survival of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Cirrhosis, Liver, Portosystemic Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
traditional chinese medicine 1 and traditional chinese medicine 2 simulant
Arm Title
group 2
Arm Type
Experimental
Arm Description
traditional chinese medicine 1 simulant and traditional chinese medicine 2
Arm Title
group 3
Arm Type
Experimental
Arm Description
traditional chinese medicine 1 and traditional chinese medicine 2
Arm Title
group 4
Arm Type
Placebo Comparator
Arm Description
traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant
Intervention Type
Drug
Intervention Name(s)
traditional Chinese medicine1 and traditional Chinese medicine 2
Other Intervention Name(s)
traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant
Intervention Description
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
Primary Outcome Measure Information:
Title
The incidence of hepatic encephalopathy
Description
The incidence of hepatic encephalopathy after 12 weeks of treatment.
Time Frame
12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TIPS treatment criteria in line with the 2017 edition of the "Expert Consensus on Transjugular Intrahepatic Portosystemic Shunt" were selected to include patients with hepatitis B cirrhosis and Child-pugh grade A and B after TIPS surgery. Patients with liver cirrhosis, portal hypertension, bleeding from esophagus and gastric varices; refractory pleural and ascites due to liver cirrhosis; incomplete portal vein/localized thrombosis in liver cirrhosis or primary and secondary prevention of cirrhosis, portal hypertension, esophagus and gastric varices bleeding. Exclusion Criteria: Severe blood coagulation disorder (PTA≤20%) or platelets lower than 30×109/L; Child-pugh classification of liver function C; Those with respiratory and circulatory dysfunction; Those whose systemic or focal infections have not been effectively controlled; Patients with moderate to severe malnutrition; Extensive primary or metastatic liver malignant tumors; Those who are highly allergic to the products and drugs used in the treatment process.
Facility Information:
Facility Name
he First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250010
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fengyan Wang, PhD

12. IPD Sharing Statement

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Integrated Traditional Chinese and Clinical Medicine for Chronic Hepatitis B and Its Complication

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