Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC).
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC). Currently there are no effective medications to cure NAFLD. Current treatments for NAFLD include weight reduction through lifestyle modification and exercise, insulin-sensitizing agents, lipid-lowering agents, and hepatoprotective drugs. However, the efficacy of these therapies is not satisfactory, some drugs may even induce liver toxicity. Thus, it is necessary to develop novel therapies that are effective and safe for the treatment of NAFLD. Hence, K Patel Phyto Extractions Pvt. Ltd. has formulated Curcuvail®. Objective of the current study is to compare efficacy, safety and tolerability of test formulation Curcuvail® by administering the medications in the adult patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD) and eligible to receive Curcuvail® as treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
Cod Research Pvt Ltd
Ahmedabad, Gujarat, India
Change in NAFLD grading based on liver USG from baseline to day 60.
NAFLD Grading: Grade 0: Lack of fat accumulation Grade 1: Mild Increase in echogenicity with normal visualization of the diaphragm and intra-hepatic vessel borders. Grade 2: Moderate increase in echogenicity with slightly impaired visualization of diaphragm and intra-hepatic vessel borders. Grade 3: Severe increase in echogenicity with markedly impaired visualization of diaphragm, intra-hepatic vessel borders, and posterior portion of the right hepatic lobe.
Time frame: 60 Days
AST to Platelet Ratio Index (APRI)
APRI score assessed as change from baseline to day 60
Time frame: 60 Days
Fibrosis score (kilopascals (kPa))
Fibrosis score evaluated by FibroScan and assessed as change from baseline to day 60 Fibrosis score: F0 to F1 (No liver scarring or mild liver scarring): 2 to 7 kPa F2 (Moderate liver scarring) : 7.5 to 10 kPa F3 (Severe liver scarring) : 10 to 14 kPa F4 (Advanced liver scarring (cirrhosis)): 14 kPa or higher
Time frame: 60 Days
Controlled Attenuation Parameter (CAP) score (decibels per meter (dB/m))
CAP score (dB/m) as evaluated by FibroScan and assessed as change from baseline to day 60.
Time frame: 60 Days
Change in lipid profile from baseline to day 60
Change in lipid profile \[total cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides represented as mg/dL\] from baseline to day 60
Time frame: 60 Days
Change in liver enzymes ALT and AST from baseline to day 60
Change in liver enzymes ALT (IU/L) and AST (IU/L) from baseline to day 60
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Time frame: 60 Days
Number (Frequency & percentage of patients) and type (severity and causality assessment) of AE (Adverse Event) and SAE (Serious Adverse Event).
AE (Adverse Event) and SAE (Serious Adverse Event) were evaluated during the study.
Time frame: Till 67 days from day of randomization