Cirrhosis Clinical Trial
Official title:
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it
is associated with insulin resistance and has been reported to improve the progression of
liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard
to the effect of liver function improvement, in a research conducted in South Korea,
approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA
was administered to them for about 10 weeks during radiation therapy for liver cancer.
Additionally, in other overseas researches, the changes in the values of total protein and
albumin were significantly smaller in the patients who underwent transarterial
chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not
administered.
The hypothesis of this study is that the serum albumin value will be increased significantly
in the cirrhotic patients with ascites to whom BCAA is administered than the patients to
whom placebo is administered.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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