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

November 16, 2021 updated by: Lili Cao, Qianfoshan Hospital

Shandong Provincial Integrated Traditional Chinese and Clinical Medicine(Chronic Hepatitis B and Its Complication) Prevention and Treatment Project

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250010
        • he First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
        • Contact:
          • fengyan Wang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
traditional chinese medicine 1 and traditional chinese medicine 2 simulant
Drug: traditional Chinese medicine1 and traditional Chinese medicine 2
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
Other Names:
  • traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant
Experimental: group 2
traditional chinese medicine 1 simulant and traditional chinese medicine 2
Drug: traditional Chinese medicine1 and traditional Chinese medicine 2
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
Other Names:
  • traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant
Experimental: group 3
traditional chinese medicine 1 and traditional chinese medicine 2
Drug: traditional Chinese medicine1 and traditional Chinese medicine 2
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
Other Names:
  • traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant
Placebo Comparator: group 4
traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant
Drug: traditional Chinese medicine1 and traditional Chinese medicine 2
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
Other Names:
  • traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hepatic encephalopathy
Time Frame: 12 weeks of treatment
The incidence of hepatic encephalopathy after 12 weeks of treatment.
12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

October 10, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-2020-1230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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