Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Granulocyte Colony Stimulating Factor Plus N-Acetyl Cysteine In Severe Alcoholic Hepatitis
Brief Summary: Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions6. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate.

G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF.

Alcoholism leads to decrease in endogenous antioxidant potential. Alcoholic liver disease (ALD) patients show low endogenous antioxidants. Chronic ethanol consumption cause selective deficiency in the availability of reduced glutathione (GSH) in mitochondria has been reported. This is due to impaired functioning of GSH transporter from cytosol to mitochondrial matrix. The effect on glutathione replenishing potential by N-acetyl cysteine (NAC) can be used to reduce oxidative stress, which also has excellent safety profile. Therefore, NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic potential factor. NAC also inhibit apoptosis and pro-inflammatory cytokine production. In a study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe alcoholic hepatitis patients with adequate nutritional support.However, these results must be viewed with caution, since the study suffered from a lack of power. In a recent study, NAC and corticosteroids combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month survival, although the final outcome at 6 month survival was not improved. There are no studies on the use of combination therapy of NAC plus G-CSF in patient with severe alcoholic hepatitis.

Therefore we plan to study the safety and efficacy of combination therapy of G-CSF and NAC in the patients with alcoholic hepatitis.


Options:
A: Arm Label: G-CSF + Erythropoietin; Type: EXPERIMENTAL; Interventions: Drug: G-CSF | Arm Label: G-CSF; Type: ACTIVE_COMPARATOR; Interventions: Drug: G-CSF+Erythropoetin | Intervention Type: DRUG; Name: G-CSF+Erythropoetin; Assigned to Arm(s): G-CSF | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF + Erythropoietin
B: Arm Label: Standard Medical therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: standard medical therapy | Arm Label: G-CSF; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF | Arm Label: G-CSF and NAC; Type: EXPERIMENTAL; Interventions: Drug: standard medical therapy, Drug: G-CSF, Drug: n-Acetylcysteine | Intervention Type: DRUG; Name: standard medical therapy; Assigned to Arm(s): G-CSF, G-CSF and NAC, Standard Medical therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF, G-CSF and NAC | Intervention Type: DRUG; Name: n-Acetylcysteine; Assigned to Arm(s): G-CSF and NAC
C: Arm Label: GCSF+SMT; Type: EXPERIMENTAL; Interventions: Drug: Granulocyte Colony Stimulating Factor | Arm Label: SMT; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Granulocyte Colony Stimulating Factor; Assigned to Arm(s): GCSF+SMT
D: Arm Label: G-CSF + Standard therapy; Type: EXPERIMENTAL; Interventions: Drug: G-CSF, Other: Standard therapy | Arm Label: Standard therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard therapy | Intervention Type: DRUG; Name: G-CSF; Assigned to Arm(s): G-CSF + Standard therapy | Intervention Type: OTHER; Name: Standard therapy; Assigned to Arm(s): G-CSF + Standard therapy, Standard therapy

Answer: B