Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial
Background: Alcoholic Liver Disease (ALD) poses a significant global health threat, contributing to millions of deaths each year. Despite the well-established link between chronic alcohol consumption and liver damage, treatment options remain limited, emphasizing the need for innovative approaches....
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KeAi Communications Co., Ltd.
2024-10-01
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| Series: | Gastroenterology & Endoscopy |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949752324000426 |
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| author | Mohammad Nezamuddin Khan Balavigneshwaran A Priyadharshini Ananthathandavan Vijayakumar T M Rajesh N A Pavithra A Sumitha A |
| author_facet | Mohammad Nezamuddin Khan Balavigneshwaran A Priyadharshini Ananthathandavan Vijayakumar T M Rajesh N A Pavithra A Sumitha A |
| author_sort | Mohammad Nezamuddin Khan |
| collection | DOAJ |
| description | Background: Alcoholic Liver Disease (ALD) poses a significant global health threat, contributing to millions of deaths each year. Despite the well-established link between chronic alcohol consumption and liver damage, treatment options remain limited, emphasizing the need for innovative approaches. Methods: An open-label, randomized controlled trial was conducted in India, involving 68 adult ALD patients over a 12-week period. The patients were randomized into two groups: one receiving standard therapy and the other receiving standard therapy along with BoozLiv™ syrup. Liver function tests, Model for End-Stage Liver Disease (MELD) scores, and safety parameters were assessed at various intervals. Results: The study demonstrated that BoozLiv™ syrup, as an add-on therapy, significantly reduced total bilirubin, direct bilirubin, SGOT, SGPT, ALP, and GGT levels compared to standard therapy alone (p < 0.05). The MELD score, indicative of liver function, showed a substantial improvement in the BoozLiv™ group (p < 0.01). Safety analysis revealed that BoozLiv™ was well-tolerated, with only minor adverse effects such as nausea and vomiting reported. Conclusion: BoozLiv™ syrup, used in conjunction with standard therapy, showed promising results in improving liver function and reducing liver damage markers in ALD patients. The safety profile was favorable and no patient has withdrawn their consent due to adverse events. Further long-term studies in larger populations are warranted to validate these findings and establish BoozLiv™ as a potential therapeutic option for ALD. |
| format | Article |
| id | doaj-art-1acf87ca63454e79b45fc509fd2e8547 |
| institution | OA Journals |
| issn | 2949-7523 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | Gastroenterology & Endoscopy |
| spelling | doaj-art-1acf87ca63454e79b45fc509fd2e85472025-08-20T02:18:47ZengKeAi Communications Co., Ltd.Gastroenterology & Endoscopy2949-75232024-10-012416817510.1016/j.gande.2024.07.007Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trialMohammad Nezamuddin Khan0Balavigneshwaran A1Priyadharshini Ananthathandavan2Vijayakumar T M3Rajesh N A4Pavithra A5Sumitha A6Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603203, Tamil Nadu, IndiaDepartment of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603203, Tamil Nadu, India; Corresponding author.Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603203, Tamil Nadu, IndiaDepartment of Gastroenterology, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203, Tamil Nadu, IndiaMMC Pharmaceuticals Ltd, Devikarumariamman Nagar, Valasaravakkam, Chennai, Tamil Nadu, 600087, IndiaMMC Pharmaceuticals Ltd, Devikarumariamman Nagar, Valasaravakkam, Chennai, Tamil Nadu, 600087, IndiaBackground: Alcoholic Liver Disease (ALD) poses a significant global health threat, contributing to millions of deaths each year. Despite the well-established link between chronic alcohol consumption and liver damage, treatment options remain limited, emphasizing the need for innovative approaches. Methods: An open-label, randomized controlled trial was conducted in India, involving 68 adult ALD patients over a 12-week period. The patients were randomized into two groups: one receiving standard therapy and the other receiving standard therapy along with BoozLiv™ syrup. Liver function tests, Model for End-Stage Liver Disease (MELD) scores, and safety parameters were assessed at various intervals. Results: The study demonstrated that BoozLiv™ syrup, as an add-on therapy, significantly reduced total bilirubin, direct bilirubin, SGOT, SGPT, ALP, and GGT levels compared to standard therapy alone (p < 0.05). The MELD score, indicative of liver function, showed a substantial improvement in the BoozLiv™ group (p < 0.01). Safety analysis revealed that BoozLiv™ was well-tolerated, with only minor adverse effects such as nausea and vomiting reported. Conclusion: BoozLiv™ syrup, used in conjunction with standard therapy, showed promising results in improving liver function and reducing liver damage markers in ALD patients. The safety profile was favorable and no patient has withdrawn their consent due to adverse events. Further long-term studies in larger populations are warranted to validate these findings and establish BoozLiv™ as a potential therapeutic option for ALD.http://www.sciencedirect.com/science/article/pii/S2949752324000426BoozLiv™erbal supplementationAlcoholic liver diseaseMELDPhyllantuhusniruriHepatic parameters |
| spellingShingle | Mohammad Nezamuddin Khan Balavigneshwaran A Priyadharshini Ananthathandavan Vijayakumar T M Rajesh N A Pavithra A Sumitha A Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial Gastroenterology & Endoscopy BoozLiv™ erbal supplementation Alcoholic liver disease MELD Phyllantuhusniruri Hepatic parameters |
| title | Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial |
| title_full | Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial |
| title_fullStr | Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial |
| title_full_unstemmed | Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial |
| title_short | Efficacy and Safety of BoozLiv™ as an add on therapy in patients with alcoholic liver disease: An open-label, randomized controlled trial |
| title_sort | efficacy and safety of boozliv™ as an add on therapy in patients with alcoholic liver disease an open label randomized controlled trial |
| topic | BoozLiv™ erbal supplementation Alcoholic liver disease MELD Phyllantuhusniruri Hepatic parameters |
| url | http://www.sciencedirect.com/science/article/pii/S2949752324000426 |
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