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

NCT05128305 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2021-11-19

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis, Liver
  • Portosystemic Shunt

Interventions

DRUG

traditional Chinese medicine1 and traditional Chinese medicine 2

We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS

Sponsors & Collaborators

  • Qianfoshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128305 on ClinicalTrials.gov