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Trial registered on ANZCTR


Registration number
ACTRN12614000193673
Ethics application status
Approved
Date submitted
13/02/2014
Date registered
24/02/2014
Date last updated
24/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chinese Herbal Medicine Formula Jieduhuayu Granules Improves Cognitive and Neurophysiological Functions in Patients with Cirrhosis Who Have Minimal Hepatic Encephalopathy
Scientific title
In Patients with Cirrhosis Who Have Minimal Hepatic Encephalopathy, Is Chinese Herbal Medicine Formula Jieduhuayu Granules Effective in Improving Cognitive and Neurophysiological Functions?
Secondary ID [1] 284099 0
None
Universal Trial Number (UTN)
U1111-1153-3122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cirrhosis Associated Minimal Hepatic Encephalopathy 291171 0
Condition category
Condition code
Oral and Gastrointestinal 291508 291508 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 291509 291509 0 0
Other neurological disorders
Alternative and Complementary Medicine 291527 291527 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288792 0
Treatment: Other
Comparator / control treatment
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.
Control group
Active

Outcomes
Primary outcome [1] 291480 0
improvement in the number connection tests part A(NCT-A) scores
Timepoint [1] 291480 0
baseline and at 15 days after treatment commencement
Primary outcome [2] 291481 0
improvement in the mini–mental state examination(MMSE) scores
Timepoint [2] 291481 0
baseline and at 15 days after treatment commencement
Secondary outcome [1] 306876 0
improvement in the mean number of P300 latency(ms).
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.
Timepoint [1] 306876 0
baseline and at 15 days after treatment commencement
Secondary outcome [2] 306877 0
improvement in the mean number of P300 wave amplitude(microvolt).
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.
Timepoint [2] 306877 0
baseline and at 15 days after treatment commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
1/07/2012
Date of last participant enrolment
Anticipated
1/04/2013
Actual
1/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5825 0
China
State/province [1] 5825 0
Guangxi

Funding & Sponsors
Funding source category [1] 288727 0
Government body
Name [1] 288727 0
National Natural Science Foundation of China (No.: 81160439).
Country [1] 288727 0
China
Funding source category [2] 288728 0
Government body
Name [2] 288728 0
Guangxi Natural Science Foundation of China (No.: 2010GXNSFD013049).
Country [2] 288728 0
China
Funding source category [3] 288729 0
Government body
Name [3] 288729 0
Guangxi health department (project ID: GZYZ-10-01).
Country [3] 288729 0
China
Primary sponsor type
Government body
Name
National Natural Science Foundation of China
Address
Shuangqing Road, Haidian District, Beijing, No. 83, PR, China, post code: 100000
Country
China
Secondary sponsor category [1] 287428 0
Government body
Name [1] 287428 0
Guangxi Natural Science Foundation of China
Address [1] 287428 0
Xinmin Road, Qingxiu District, nanning, No. 83, Guangxi, PR, China,post code: 530000
Country [1] 287428 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290565 0
Ethics Committee of Guangxi health department
Ethics committee address [1] 290565 0
Ethics committee country [1] 290565 0
Date submitted for ethics approval [1] 290565 0
Approval date [1] 290565 0
Ethics approval number [1] 290565 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46270 0
Dr Yaochun
Address 46270 0
Department of Hepatology, First Affiliated Hospital, Guangxi University of Chinese Medicine, No. 2, Yuanhu Rd, Nanning, Guangxi, PR, China, post code:530023.
Country 46270 0
China
Phone 46270 0
+8618907715711
Fax 46270 0
Email 46270 0
[email protected]
Contact person for public queries
Name 46271 0
Huang Guochu
Address 46271 0
Department of Hepatology, First Affiliated Hospital, Guangxi University of Chinese Medicine, No. 2, Yuanhu Rd, Nanning, Guangxi, PR, China, post code:530023.
Country 46271 0
China
Phone 46271 0
+8613084993691
Fax 46271 0
Email 46271 0
[email protected]
Contact person for scientific queries
Name 46272 0
Huang Guochu
Address 46272 0
Department of Hepatology, First Affiliated Hospital, Guangxi University of Chinese Medicine, No. 2, Yuanhu Rd, Nanning, Guangxi, PR, China, post code:530023.
Country 46272 0
China
Phone 46272 0
+8613084993691
Fax 46272 0
Email 46272 0
[email protected]

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