Randomized double-blind controlled trial of Kelong capsule in the treatment of NAFLD

Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: placebo group:Oral placebo;Kelong capsule group:Oral Kelong capsule; CONDITION: NAFLD PRIMARY OUTCOME: The liver cap level decreased by at least 30% from baseline or returned to the normal range (within 239db / M);Serum ALT level decreased by at least 30% from baseline or returned to the normal range (within 40u / L); SECONDARY OUTCOME: Changes of lipid metabolism: triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL‐C), high density lipoprotein cholesterol (HDL‐C);;Changes of other liver function indexes: aspartate aminotransferase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (AKP), total bilirubin (TBIL), direct bilirubin (DBIL);Changes in body measurements: body mass inde X(BMI), waist circumference, hip circumference, waist hip ratio;Changes of TCM syndrome score;Changes of insulin resistance inde X(HOMA‐IR);; INCLUSION CRITERIA: (1) Meet the diagnostic criteria of nonalcoholic fatty liver disease; (2) Meet the diagnostic criteria of damp heat accumulation syndrome in traditional Chinese medicine; (3) The age is between 18 and 65 years old; (4) The level of serum alanine aminotransferase (ALT) increased slightly, which was defined as the increase of ALT = 2.5 times the upper limit of normal; (5) Liver cap = 259db / M (moderate fatty liver); (6) Informed consent, voluntary test, and the process of obtaining informed consent shall comply with the provisions of GCP.
Epistemonikos ID: 3ab55a888602f7d05476c6cf9aafdfbc84bd401d
First added on: Aug 26, 2024