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 (Record no. 20662)
[ view plain ]
| 000 -LEADER | |
|---|---|
| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240223110031.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240223b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 22891 |
| Author | Patel, Ghanashyam |
| 245 ## - TITLE STATEMENT | |
| Title | 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 |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.17(3), Jul-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | M P |
| Name of publisher, distributor, etc. | BRNSS Publication Hub. |
| Year | 2023 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 218-225p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Mandsaur B.R. Nahata Smriti Sansthan |
| Title | International journal of green pharmacy |
| International Standard Serial Number | 0973-8258 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.greenpharmacy.info/index.php/ijgp/article/view/3472 |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Permanent Location | Current Location | Shelving location | Date acquired | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| School of Pharmacy | School of Pharmacy | Archieval Section | 2024-02-23 | 2024-0183 | 2024-02-23 | 2024-02-23 | Articles Abstract Database |