A prospective, multicentre, observational study of patients with chronic cholestatic liver diseases receiving Udiliv and reg; in India: splendid study

Lawate, Parimal; Rooprai, Ramesh; Choudhury, Gourdas; Dutta, Sangitanjan

doi:10.18203/2319-2003.ijbcp20164135

Cited by 2 publications

(4 citation statements)

References 18 publications

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“…Of these, Liv.52 has been widely studied for the therapy of CLD [ 20 ]. The outcome of the present study is in line with a phase IV study on liver care supplement ursodeoxycholic acid conducted in 235 patients with varied liver diseases (ALD, NAFLD, hepatitis) demonstrating a reduction in liver enzymes (ALT, AST) by 46%-55% in 12 weeks [ 21 ].…”

Section: Discussionsupporting

confidence: 76%

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study

Shivnitwar,

Gilada,

Rajkondawar

et al. 2024

Cureus

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Background The hepatoprotective function of polyherbal formulation Liv.52 in chronic liver diseases is well recognized in published literature. The objective of this open-label, phase IV study was to further strengthen and validate its safety and effectiveness using a large patient pool in a real-world scenario and provide scientific data on symptomatic improvement and supportive treatment in liver function with improvement in quality of life. Methods Adult patients of either sex with one or more clinical symptoms like fatigue, nausea, anorexia, abdominal pain or discomfort, muscle cramps, jaundice, or any other signs and symptoms with a history suggestive of mild-to-moderate hepatic disorders like alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), drug-induced hepatotoxicity, or hepatitis were treated with two Liv.52 DS tablets (oral) twice daily for 12 weeks. Results Out of the 1000 enrolled patients, 962 (96%) completed the study with the following subgroups ALD: 375 (38.9%), NAFLD: 379 (39.3%), drug-induced hepatotoxicity: 78 (8.1%), hepatitis: 130 (13.5%). The mean age of enrolled patients was 37.7 years, and the majority of them, 785 (78.5%) were men. The common adverse events observed (with >1.5% incidence) in the study were abdominal pain: 26 (2.6%) and headache: 17 (1.7%). Liv.52 showed statistically significant improvement (P<0.0001) in various clinical signs and symptoms in the majority of patients namely, fatigue: 357/723 (49%), anorexia: 485/620 (78.2%), jaundice: 48/52 (92%). Majority of the patients showed significant improvements from baseline to end of 12 weeks in the liver function test parameters namely, aspartate aminotransferase: 633/840 (75.36%), alanine aminotransferase: 592/729 (81.21%), serum bilirubin: 244/347 (70.32%), alkaline phosphatase: 279/355 (78.59%) with P<0.0001 for all parameters. Statistically significant improvement (P<0.005) was also seen in all the components of the chronic liver disease questionnaire (CLDQ) scores from baseline to 12 weeks. Conclusions The study demonstrated that Liv.52 was hepatoprotective and well tolerated in the study population after treatment for 12 weeks. Significant improvements were seen in clinical signs and symptoms, laboratory parameters of liver function, and CLDQ scores from baseline to 12 weeks. No significant or new safety signals emerged from this study.

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Section: Discussionsupporting

confidence: 76%

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study

Shivnitwar,

Gilada,

Rajkondawar

et al. 2024

Cureus

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“…Chronic cholestatic liver disease (CCLD) comprises a complex spectrum of hereditary and acquired hepatobiliary disorders, resulting in impaired bile secretion or diminished bile formation. 1,2 The disease course is heterogenous most likely involving genetic predisposition and exposure to environmental factors. 2,3 CCLD increases the risk for several complications and rising morbidity and mortality rates associated with the underlying condition and poses a significant healthcare burden.…”

Section: Introductionmentioning

confidence: 99%

“…4 This hydrophilic bile acid works by membrane stabilization, cytoprotection, and immunomodulation of affected liver cells. 1 The American Association for the study of liver diseases (AASLD) and the European association for the study of the liver (EASL) recommend UDCA as the life-long treatment of choice for PBC, with a recommended dose of 13-15 mg/kg/day. 12,13 Treatment with UDCA prevents further progression of PBC, such that duration of survival can be improved by 16-20 years.…”

Section: Introductionmentioning

confidence: 99%

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Epidemiology and treatment practices of chronic cholestatic liver disease in India: a physician survey-based study

Ravindra

Lahoti

Das³

2022

Int J Sci Rep

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Background: Chronic cholestatic liver disease (CCLD) constitutes an intricate array of liver diseases in India. A physician-based survey was conducted to understand the prevalence, current treatment approaches, and gaps in the management of CCLD in India. Methods: A total of 215 physicians participated to complete a questionnaire comprising 35 questions related to the prevalence and current treatment of CCLD and assess gaps in its management. Results: Most physicians (53.5%) reported liver disorders with cholestasis to be prevalent in 10-20% of patients, while 34.9% reported their prevalence in 21-30% of patients. Alcoholic liver disease with cholestasis (CCLD [ALD]) was reported in 10-20% of patients and 21-30% of patients by 33.5% and 37.2% of physicians, respectively. Drug-induced liver disease with cholestasis (CCLD [DILI]) was reported to be present in 5-10% of patients by 34.9% of physicians. Ursodeoxycholic acid (UDCA) was found to be used by 60% physicians in >50% of patients with CCLD (ALD), commonly for a period of 4-12 weeks (48.4% physicians), while it was used for 12-24 weeks by 38.1% physicians in CCLD (DILI); for both conditions, the preferred dose was 10-15 mg/kg body weight. UDCA was reported to have good tolerability and efficacy by most physicians for both conditions. Conclusions: In light of scarce data on CCLD prevalence and management approaches in India, the present survey findings provide useful insights on its prevalence in India and support the use of UDCA therapy for the management of its symptoms.

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A prospective, multicentre, observational study of patients with chronic cholestatic liver diseases receiving Udiliv and reg; in India: splendid study

Cited by 2 publications

References 18 publications

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study

Epidemiology and treatment practices of chronic cholestatic liver disease in India: a physician survey-based study

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