Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis

Launched by HOSPITAL GENERAL DR. MANUEL GEA GONZÁLEZ · Nov 5, 2018

Keywords

ClinConnect Summary

Double-blind clinical trial.

Two groups:

* GROUP A (standard treatment): Prednisone 40 mg a day + Placebo (manufactured by the same laboratory with the same presentation and physical appearance as the nanoemulsifyied pomegranate seed oil rich in Omega 5 fatty acid)
* GROUP B (combined treatment): Prednisone 40 mg per day + nanoemulsifiyied pomegranate seed oil rich in Omega 5 fatty acid (2 capsules of 0.64g each / day).

STUDY UNIVERSE: Patients\> 18 years old, indistinct gender, with a diagnosis of severe alcoholic hepatitis.

STUDY POPULATION: Patients with clinical and laboratory diagn...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with clinical and biochemical criteria for severe alcoholic hepatitis (Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound)
• • history of chronic alcohol intake (greater than 50 g / day for at least 3 months),
• • leukocytosis (neutrophilia)
• • elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2)
• • discriminant function greater than 32.
• Exclusion Criteria:
• • Hepatorenal syndrome (serum creatinine \>2.5mg/dl)
• • Hepatocellular carcinoma.
• • Hepatitis C virus, hepatitis B virus or human immunodeficiency virus infection.
• • Cancer, heart disease, neurological or severe neurological.
• • Patients taking pentoxifylline, steroids, S-adenosyl L- methionine or N-Acetylcysteine.