The Role of Branch chain amino acid granules in treatment of sarcopenia in cirrhotic patient.

Phase 3

• Conditions: sarcopenia hand grip strength BIA CT scan; sarcopenia BCAA cirrhosis

• Registration Number: TCTR20190904006
• Lead Sponsor: EA Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Study Completion: 2020-09-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

-Age between 18 to 70 years old.
-Meet criteria for cirrhosis and sarcopenia as mentioned above
-Agree to sign inform consent

Exclusion Criteria

-Found hepatocellular carcinoma (HCC) or other malignancy that life expectancy <6 months
-Prior treatment with pegylated interferon in HCV treatment within 6 months
-Prior treatment with Beta-blocker drug within 3 months
-Uncontrolled diseases defined by any of the following
oUncontrolled hypertension (BP>140/90 mmHg despite optimal medications)
oUncontrolled DM (HbA1C>7.5% despite optimal medications)
oAdvanced stage CKD (GFR<30 ml/min/1.73m2 )
oUncontrolled ascites (detectable ascites by physical examination despite optimal diuretics)
-Pregnancy or lactation
-Refuse to participate the study
-MELD score ≥ 20 points

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sarcopenia at baseline and at month 6 Mean change in hand grip strength and percent change in CT Skeletal muscle index

Secondary Outcome Measures

Name	Time	Method
percent change in albumin AFP HCC CTP MELD at baseline, month 3,month 6,month 9 blood sample analysis machine