Chinese Herbal Medicine Formula Jieduhuayu Granules Improves Cognitive and Neurophysiological Functions in Patients with Cirrhosis Who Have Minimal Hepatic Encephalopathy

Completed

• Conditions: Cirrhosis Associated Minimal Hepatic Encephalopathy; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12614000193673
• Lead Sponsor: ational Natural Science Foundation of China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. All patients diagnosed as having cirrhosis at the Department of Hepatology of the First Affiliated Hospital of Guangxi University of Chinese Medicine, were candidates for enrollment.
2. Patients’ Child-Turcotte-Pugh (CTP) class were A or B.
3. Two or more positive indicators of NCT-A, the DST, the MMSE and the event related potential P300.

Exclusion Criteria

1. Overt HE or a history of overt HE;
2. Patients’ Child-Turcotte-Pugh (CTP) class were C;
3. Psychological or neurological disorders;
4. History of recent (4 weeks) use of Tranquilizers or central nervous system depressants like psychotropic drugs or antiepileptics;
5. History of recent (4 weeks) alcohol intake;
6. Gastrointestinal bleeding, infection, or recent (2 weeks) use of antibiotics;
7. Electrolyte imbalance due to the recent use (2weeks) of diuretics;
8. Body temperature at 37.5 degrees celsius or higher;
9. A history of shunt surgery or transjugular intrahepatic portosystemic shunt(TIPS) for portal hypertension;
10. Renal impairment;
11. Hepatocellular carcinoma;
12. Severe diseases such as congestive heart failure, pulmonary disease;
13. Inability to perform NCT-A tests and MMSE tests because of hearing impairs and/or poor vision.
14. Illiterate or uncooperative patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in the number connection tests part A(NCT-A) scores[baseline and at 15 days after treatment commencement];improvement in the mini–mental state examination(MMSE) scores[baseline and at 15 days after treatment commencement]

Secondary Outcome Measures

Name	Time	Method
improvement in the mean number of P300 latency(ms).<br>the P300 is thought to reflect processes involved in stimulus evaluation or categorization. When recorded by electroencephalography (EEG), it surfaces as a positive deflection in voltage with a latency (delay between stimulus and response), and any score higher than 280ms is considered abnormal.we use Nicolet Bravo S403 brain evoked potential instrument to measure this outcome.[baseline and at 15 days after treatment commencement];improvement in the mean number of P300 wave amplitude(microvolt).<br>the P300 is thought to reflect processes involved in stimulus evaluation or categorization. When recorded by electroencephalography (EEG), it surfaces as a positive deflection in voltage with a latency (delay between stimulus and response), and any score higher than 280ms is considered abnormal.we use Nicolet Bravo S403 brain evoked potential instrument to measure this outcome.[baseline and at 15 days after treatment commencement]