Patel, Ghanashyam
Evaluation of the safety and efficacy of curcuvail® in patients with non-alcoholic fatty liver disease - a prospective randomized, double blind, placebo controlled, parallel group study - Vol.17(3), Jul-Sep - M P BRNSS Publication Hub. 2023 - 218-225p.
Introduction: The prevalence of non-alcoholic fatty liver disease (NAFLD) has increased to 38.2%. Curcuminoids
hold promise, but curcumin’s clinical use is limited. CurcuVail® improves absorption and effectiveness. This
study assesses CurcuVail®’s efficacy, safety, and tolerability in NAFLD patients. Materials and Methods: We
conducted a prospective, double-blind, placebo-controlled, and parallel-group study in 30 NAFLD patients.
Subjects were assigned at random to receive either CurcuVail® or Placebo. The primary efficacy endpoint was
the improvement in fatty liver grading based on liver ultrasound from baseline to day 60. Secondary efficacy
endpoints included changes in aspartate aminotransferase (AST) to platelet ratio index (APRI) score, Fibrosis
score, controlled attenuation parameter (CAP) score, total cholesterol (TC), and liver enzymes. Results: The
demographic data of both groups were identical. The overall mean change in NAFLD grading based on liver
USG from baseline to the end of treatment was observed to be ?0.27 ± 0.458 in the test group and ?0.07 ±
0.258 in the placebo group. Remarkable and statistically significant differences were observed between the
test and placebo treatment groups from baseline to the end of treatment in various parameters, including mean
changes in APRI score (?0.38 ± 0.190 vs. ?0.18 ± 0.286), Fibrosis Score (?0.91 ± 0.364 vs. ?0.17 ± 0.135),
and CAP score (?20.67 ± 6.651 vs. ?5.27 ± 3.105). Significant reductions were also observed in mean changes
of TC, serum alanine aminotransferase, and serum AST from baseline to the end of treatment. No safety or
tolerability issues were reported. Discussion: CurcuVail® was found to improve NAFLD grading, FibroScan®
parameters, and biochemical markers associated with NAFLD with a good safety profile. However, longterm
investigations are necessary to fully evaluate the clinical efficacy and safety profile of the test product.
Conclusion: CurcuVail®, a dietary supplement, was found to be clinically safe and effective in NAFLD subjects
after 60 days of administration.
PHARMACEUTICS
Evaluation of the safety and efficacy of curcuvail® in patients with non-alcoholic fatty liver disease - a prospective randomized, double blind, placebo controlled, parallel group study - Vol.17(3), Jul-Sep - M P BRNSS Publication Hub. 2023 - 218-225p.
Introduction: The prevalence of non-alcoholic fatty liver disease (NAFLD) has increased to 38.2%. Curcuminoids
hold promise, but curcumin’s clinical use is limited. CurcuVail® improves absorption and effectiveness. This
study assesses CurcuVail®’s efficacy, safety, and tolerability in NAFLD patients. Materials and Methods: We
conducted a prospective, double-blind, placebo-controlled, and parallel-group study in 30 NAFLD patients.
Subjects were assigned at random to receive either CurcuVail® or Placebo. The primary efficacy endpoint was
the improvement in fatty liver grading based on liver ultrasound from baseline to day 60. Secondary efficacy
endpoints included changes in aspartate aminotransferase (AST) to platelet ratio index (APRI) score, Fibrosis
score, controlled attenuation parameter (CAP) score, total cholesterol (TC), and liver enzymes. Results: The
demographic data of both groups were identical. The overall mean change in NAFLD grading based on liver
USG from baseline to the end of treatment was observed to be ?0.27 ± 0.458 in the test group and ?0.07 ±
0.258 in the placebo group. Remarkable and statistically significant differences were observed between the
test and placebo treatment groups from baseline to the end of treatment in various parameters, including mean
changes in APRI score (?0.38 ± 0.190 vs. ?0.18 ± 0.286), Fibrosis Score (?0.91 ± 0.364 vs. ?0.17 ± 0.135),
and CAP score (?20.67 ± 6.651 vs. ?5.27 ± 3.105). Significant reductions were also observed in mean changes
of TC, serum alanine aminotransferase, and serum AST from baseline to the end of treatment. No safety or
tolerability issues were reported. Discussion: CurcuVail® was found to improve NAFLD grading, FibroScan®
parameters, and biochemical markers associated with NAFLD with a good safety profile. However, longterm
investigations are necessary to fully evaluate the clinical efficacy and safety profile of the test product.
Conclusion: CurcuVail®, a dietary supplement, was found to be clinically safe and effective in NAFLD subjects
after 60 days of administration.
PHARMACEUTICS