None listed
Conditions
Brief summary
Minimal hepatic encephalopathy (MHE) is a special type of hepatic encephalopathy (HE). MHE patients’ operating ability and response capability are reduced to a certain level, raising the risks of accidents. Also, if MHE patients are not treated correctly, their MHE will stand a great chance of progressing to hepatic coma, which increases the mortality of those patients. Because of those factors above, we conducted a randomized trial to observe the effects of a particular Chinese herbal formula (Jieduhuayu granules) on the neurophysiological functions of cirrhotic patients with MHE, to seek out an effective formula of Chinese herbal medicine for MHE.
Interventions
There were four treatment groups in the study. in the control group(CG), patients received complex vitamin B tablets (produced by Shanghai Xinpasi Pharmacy Co., Ltd.), each tablet contains Vitamin B13mg, vitamin B2 1.5mg, vitamin B6 0.2mg, nicotinamide 10mg, calcium pantothenate 1mg; 2 tablets/time, 3 times/day,oral; in the herbal medicine therapy group, patients received same treatment as the CG plus the Jieduhuayu granules (10g/bag, produced by the Department of Formulation, First Affiliated
There were four treatment groups in the study. in the control group(CG), patients received complex vitamin B tablets (produced by Shanghai Xinpasi Pharmacy Co., Ltd.), each tablet contains Vitamin B13mg, vitamin B2 1.5mg, vitamin B6 0.2mg, nicotinamide 10mg, calcium pantothenate 1mg; 2 tablets/time, 3 times/day,oral; in the herbal medicine therapy group, patients received same treatment as the CG plus the Jieduhuayu granules (10g/bag, produced by the Department of Formulation, First Affiliated Hospital, Guangxi University of Chinese Medicine, Nanning, Guangxi, China. SFDA Approval No. Z20110004), 1bag/time, 2 times/day, oral, so that patients passed 2-3 semisoft stools per day; in the lactulose therapy group, patients received same treatment as the CG plus lactulose (produced by Abbott Healthcare Products B.V.), 15ml/time, 2 times/day, oral, so that patient passed 2-3 semisoft stools per day; in the herbal medicine combine with lactulose therapy group, patients received plus the complex vitamin B tablets, the Jieduhuayu granules and the lactulose (same dosage and mode of administration as above, respectively). All those four groups were treated for 15 days. Compliance with the therapies were assured by counting the number of bags of drugs consumed and by ensuring increased stool frequency and a change to a softer consistency.
Sponsors
National Natural Science Foundation of China
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Outcome results
None listed