One dosage of Chinese herbal medicine by oral administration per day for 8 weeks. For patients who cannot take oral medicine can be switched to colon route by the colonic therapy system（IMS-100A produced by Sunny Medical in Beijing China).

Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.

Acute on Chronic Liver Failure

Traditional Chinese Medicine

Hepatitis B

One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.

Chinese herbal medicine

SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.

Control (blank)

302 military hospital of China

Beijing Ditan hospital

Beijing youan hospital

Fuzhou infectious hospital

Xiamen hospital of traditional Chinese medicine

Hubei hospital of traditional Chinese medicine

Tongji hospital, Huazhong university of science and technology

The first affiliated hospital of Hunan university of traditional Chinese medicine

Jilin hepatology hospital

The sixth people's hospital of Shenyang

Shanghai public health clinical center

Shuguang hospital, Shanghai university of traditional Chinese medicine

Chengdu public health clinical center

The second people's hospital of Tianjin

Hangzhou Xixi hospital

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Study on the Optimal Strategy for Acute-on-chronic Liver Failure Combined With Traditional Chinese and Modern Medicine: a Multi-center, Randomized and Controlled Study

transplant free survival at the time point of week 12

transplant free survival at the time point of week 24

compare the MELD score between the two arms. MELD is the abbreviation of model for end-stage liver disease involving serum bilirubin, creatinine, international normalized ratio (INR) and sodium.

compare the Child-Pugh score between the two arms. Child-Pugh score is the panel involving the serum bilirubin, coagulation function, albumin and the complication of hepatic encephalopathy and ascites.

compare the life quality based on WHOQOL-BRIEF between the two arms

incidence of liver related complications of the two arms including infections, encephalopathy, hepatorenal syndrome (HRS), and gastrointestinal bleeding.

Man Gong

Professor

Beijing 302 Hospital

Beijing YouAn Hospital

ShuGuang Hospital

Sun Yat-sen University

Huazhong University of Science and Technology

Fuzhou Infectious Hospital

Public Health Clinical Center of Chengdu

Hepatology hospital of Jilin Province

Shanghai Public Health Clinical Center

Guangxi University of Chinese Medicine

Hubei Hospital of Traditional Chinese Medicine

Beijing Ditan Hospital

Shenzhen traditional Chinese medical hospital

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Shenzhen Third People's Hospital

Tianjin Second People's Hospital

Hepatic Encephalopathy

30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days

Lactulose

10 grams by intravenous way for 24 hours. Duration of therapy: 7 days

L-ornithine L-aspartate

2 tablets (400mg) three times daily. Duration of therapy: 7 days

Rifaximin

Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days.
Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days.
Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days.

Placebo

Hospital General de Mexico

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients

Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)

Side or adverse effect will be defined as an undesirable secondary effect which occurs in addition to the desired therapeutic effect of a drug or medication.
Non serious side effect will be defined as an undesirable secondary effect that does not represents a risk for patient´s life or function.
Particularly we will addressed: Diarrhea, bloating, nausea, vomiting, elevation of serum creatinine, flatulence, abdominal pain, constipation, headache, dizziness
Serious side effect will be defined as an undesirable secondary effect that represents a risk for patient´s life or function.
Particularly we will addressed: allergic reactions.

MARIA DE FATIMA HIGUERA DE LA TIJERA

MD, MSc.

The covered stents were used for TIPS The SPSS will be embolized during the procedure of TIPS

The covered stents were used for TIPS No embolization of SPSS will be performed during TIPS

Liver Cirrhosis

TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. TIPS revision was planned if any evidence of shunt dysfunction was seen.

TIPS

Embolization of SPSS was conducted via the same jugular vein before TIPS implantation. The major procedures included (a)angiography of SPSS after successful intrahepatic puncture of a branch of the portal vein and (b)embolization of SPSS with coils of varying diameters, which resulted in the SPSS disappearing at postembolization angiography.

embolization

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy: a Prospective、Open-labeled、Randomized、Controlled Trial

Guohong Han

M.D., Ph.D.

Fourth Military Medical University

L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo (sterile water, 6 ampuoles of 10 ml each) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Cirrhosis of Liver

Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Department of Gastroenterology, D.M.C. and Hospital

G.B. Pant Hospital

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

Mental state grade according to West Haven criteria for Hepatic encephalopathy

Change in blood ammonia levels will be measured at baseline and after 5 days of treatment

Mortality rate in the two groups at 4 weeks will be compared

The total length of hospital stay (number of days) in each group will be compared.

Change in serum cytokine levels (Interleukin-1, Interleukin-6, Interleukin-10 and TNF-alpha will be measured at baseline and after 5 days of treatment.

Prof. Sandeep S Sidhu

Dayanand Medical College and Hospital

Administration of OP (OCR-002) during 5 days in addition to standard treatment of gastrointestinal bleeding.

Administration of control infusion (saline infusion) during 5 days in addition to standard treatment of gastrointestinal bleeding.

Gastrointestinal Bleeding

Cirrhosis

Phase A: Open-label scalating dose of OP. Treatment will be initiated at 1/3 of the final dose and will be scalated every 12 hours up to the full dose, except if there are problems of tolerance. Duration of the infusion 5 days.
Phase B: Comparative study of experimental drug vs placebo for 5 days OP (OCR-002) at a dose of 10 g diluted in 150 ml of water for injection administered as a continuous i.v. infusion for 24 hours (8.3 ml/h)during 5 days.

Ornithine-phenylacetate

Hospital Vall Hebron

Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding

Venous plasma ammonia will be assessed within 60 minutes of extraction in samples withdrawn every 12 hours during the first 48 hours and once a day during the second 72 hours. The concentration of ammonia will be used to decide: a)dose escalating in the initial phase (first 48 hours) of part A and b)discontinuation of treatment in the second phase (second 72 hours) of part B. Blood samples will be processed immediately after being withdrawn to separate plasma under cold conditions. Ammonia will be measured enzymatically in a Cobas Integra analyzer.

Hepatic encephalopathy (HE) is a common complication of cirrhosis,characterized by a myriad of neurological manifestations,diverse underlying liver disorders, and a variety of precipitating factors. For evaluated the presence and severity of HE the CHESS, and WEST-HAVEN scales will be performe because are adequate for clinical trials.

ornithine/krvarenje

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Embolization of Large Spontaneous Portosystemic Shunts for the Prevention of Post-TIPS Hepatic Encephalopathy

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding

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