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Clinical study on the therapeutic effects of JianPi HuaZhuo XingNao formula on patients with MHE, caused by CHB induced hepatocirrhosis.

Clinical study on therapeutic effect of JianPi HuaZhuo XingNao formula for patients with minimal hepatic encephalopathy caused by chronic hepatitis B induced hepatocirrhosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015280
Enrollment
Unknown
Registered
2018-03-19
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal hepatic encephalopathy

Interventions

Experimental Group:JianPi HuaZhuo XingNao formula plus basic treatment
Control Group:JianPi HuaZhuo XingNao formula placebo plus basic treatment

Sponsors

Dongzhimen hospital affiliated to Beijing university of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Participants should meet all the criteria that follow: 1. Diagnosed with chronic hepatitis B, referring to the Guideline [Chinese Society of Hepatology Diseases, Chinese Medical Association. The guideline of prevention and treatment for chronic hepatitis B (2010 version)]; 2. Diagnosed with hepatocirrhosis by liver ultrasound, CT, MRI or other imaging examination, or histological evidence of hepatocirrhosis (including stage 4 liver fibrosis); 3. Diagnosed with minimal hepatic encephalopathy by neurophysiology and neuropsychology test; 4. Being voluntary participants to this project, after having signed the informed consent form.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria should not be enrolled: 1. Aged under 18 or over 75 years; 2. HBV infection was ruled out for the primary cause of hepatocirrhosis; 3. With severe complications of hepatocirrhosis (e.g., electrolyte disorders, gastrointestinal bleeding, infections); 4. Diagnosed with a mental illness or cerebrovascular disease; 5. Has taken a sedative in the last four weeks; 6. Long-term drinkers for at least five years (equivalent to ethanol: 40g/day for male or 20g/day for female) or heavy drinkers (equivalent to ethanol: 40g/day) within two weeks; 7. Body temperature over 37.5 degree C; 8. Accompanied by cardiovascular, pulmonary, renal, endocrine, nerve and hematology diseases; 9. Diagnosed malignant tumor; 10. Can not cooperate with this research due to other reasons.

Design outcomes

Primary

MeasureTime frame
incidence of developing overt hepatic encephalopathy.;

Secondary

MeasureTime frame
Number connection test A (NCT-A);Digital sign test (DST);SF-36 survey;Chronic liver disease questionnaire;

Countries

China

Contacts

Public ContactLi Xiaoke

Dongzhimen hospital affiliated to Beijing university of Chinese medicine

lixiaoke@bucm.edu.cn+86 13810622664

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026