Hepatoprotective Effects of Liv.52 in Chronic Liver Disease Preclinical, Clinical, and Safety Evidence: A Review
Abstract
:1. Introduction
2. Liv.52 Formulation
2.1. Hepatoprotective Effect of Individual Component of Liv.52
2.1.1. Cichorium intybus
2.1.2. Capparis spinosa
2.1.3. Solanum nigrum
2.1.4. Cassia occidentalis
2.1.5. Terminalia arjuna
2.1.6. Achillea millefolium
2.1.7. Tamarix gallica
2.1.8. Mandur bhasma
2.2. Mechanism of Action of Liv.52
2.3. Preclinical Studies: Hepatoprotective Effects of Liv.52
2.3.1. Hepatoprotective Effect
2.3.2. Antioxidant Effect and Radiation Hazard
2.4. Clinical Studies: Hepatoprotective Effect of Liv.52 in Different Clinical Conditions
2.4.1. Tuberculosis
2.4.2. Alcoholic Liver Disease
2.4.3. Viral Hepatitis
2.4.4. Non-Infectious Chronic Liver Disease
2.4.5. Liver Function in Pregnancy
2.4.6. Liver Cirrhosis
2.4.7. Non-Alcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
2.4.8. Hepatomegaly Syndrome
2.4.9. Safety
Sr. No. | Author | Year | Type of Study | Aim | Findings Description | Reference |
---|---|---|---|---|---|---|
Hepatoprotective effect | ||||||
1 | Vidyashankar et al. | 2012 | In vitro study | Evaluate Liv.52 in oleic acid-induced non-alcoholic fatty liver disease (NAFLD) in HepG2 cells. |
| [38] |
2 | Vidyashankar et al. | 2010 | In vitro study | Evaluate the hepatoprotective effect of Liv.52 against oxidative damage induced by tert-butyl hydroperoxide (t-BHP) in HepG2 cells. |
| [36] |
3 | Mitra et al. | 2008 | In vitro study | Determine whether ethanol and Liv.52 can modulate PPARc and TNFα induction in human hepatoma cells, HepG2. | Liv.52 is capable of attenuating ethanol-induced expression of TNFα and abrogating ethanol-induced suppression of PPARc in liver cells, suggesting its immunomodulatory and hepatoprotective effect. Liv.52 reverses the effects of carbon-tetrachloride-induced elevated activities of hepatic enzymes and NADPH-dependent lipid peroxidation. | [35] |
4 | Cimen et al. | 2020 | In vivo study | Evaluate effect of Liv-52 on liver ischemia-reperfusion damage in rats | Liv-52 is effective in reducing markers of liver damage and improving the histopathological condition of the liver tissue in the context of liver I/R injury. | [9] |
5 | Sandhir et al. | 1999 | In vivo study | Evaluate hepatoprotective effects of Liv-52 on ethanol-induced hepatic damage in rats. | Liv-52 prevents ethanol-induced increase in the activity of the enzyme gamma-glutamyl transpeptidase and decreases ethanol-accentuated lipid peroxidation. | [40] |
6 | Kataria et al. | 1997 | In vitro study | Evaluate effect of Liv.52 and Kumaryasava on growth and hepatic enzymes of CCl4 treated rats | Liv.52 and Kumaryasva both provide a certain amount of protection and correct liver dysfunction due to CCl4-induced hepatotoxicity. Also, the combination stimulates regeneration of hepatic and microsomal enzyme decreased due to CCl4 toxicity. | [41] |
Antioxidant effect and radiation hazard | ||||||
1 | Jagetia et al. | 2006 | In vivo study | To evaluate radioprotective activity of Liv 52 in mice |
| [46] |
Sr No. | Study and Origin | Study Design | Treatment Duration | Country | Participant | Sample Size (Commenced, Completed) | Intervention | Outcome Measures | Results | References |
---|---|---|---|---|---|---|---|---|---|---|
Drug-induced hepatotoxicity: tuberculosis | ||||||||||
1 | Choijamts et al.; 2018 | Double Blind Placebo Controlled Study | 6 months | Mongolia | Patients aged between 18 years to 60 years under ATT. | Liv 52 DS (47,47), Placebo (43,43) | Liv 52 DS- 2 tablets twice daily. | LFT (SGOT, SGPT, serum alkaline phosphatase, and serum bilirubin), hemoglobin, serum protein | Compared to placebo, significant reduction was observed in LFT (SGOT, SGPT, serum alkaline phosphatase, and serum bilirubin) (p < 0.05). Hemoglobin improved from 13.17 ± 1.70 to 13.29 ± 1.21 with a significance of p < 0.004. | [51] |
Non-alcoholic fatty liver disease | ||||||||||
1 | Siregar et al., 2021 | Prospective, interventional study | 2 months | Indonesia | Patients aged between 18 and 65 years with NAFLD | Liv.52 (60,60) | Liv.52 DS- 2 tablets twice daily for 2 months. | LFT (SGOT, SGPT), ultrasound, NAFLD Fibrosis Score. | Compared to placebo, Liv.52 group showed greater reduction in the fibrosis score for NAFLD. Hepatomegaly decreased to 42% of the participants. SGOT and SGPT levels significantly decreased (p < 0.0339 and p < 0.0022, respectively.) | [6] |
Non-alcoholic steatohepatitis (NASH) | ||||||||||
1 | Maity et al., 2015 | Randomized controlled study | 12 weeks | India | Patients aged between 18 and 65 years with non-alcoholic steatohepatitis | Liv.52 DS group (19,19); UDCA (16,16). | Liv.52 DS -2 tablets twice daily; 600 mg of UDCA thrice daily for 12 weeks | SGPT, SGOT, ALT, serum bilirubin, total protein, albumin and globulin | Compared to UDCA, Liv.52 showed faster clinical and biochemical recovery. Significant decrease was noted in the levels of SGPT(p < 0.004), SGOT (p < 0.033), and ALP (p < 0.008). | [71] |
2 | Ghosh et al., 2014 | Open clinical study | 3 months | India | Patients suffering from steatohepatitis. | Liv.52 DS (50) | Liv.52 DS- 2 tablets twice daily for a period of 3 months | ALP, total protein, total cholesterol, random blood sugar, TSH, serum triglyceride | Liv.52 showed improvement (p < 0.0001) in clinical and liver function parameters along with ultraso-nographic and NAFLD scores. | [72] |
Viral hepatitis | ||||||||||
1 | Kar et al., 2009 | Open-labeled clinical trial | 6 months | India | Patients aged 18–60 years with hepatitis B infection | HD-03/ES (51,51) | HD-03/ES- 2 capsules twice daily for 6 months. | LFT, serum HBsAg, HBeAg and HBV DNA | Liv.52 showed significant reduction of ALT values from 71.2 ± 16.3 to 36.4 ± 6.8 (p < 0.01) and a significant HBeAg loss (27.4%) and HBV DNA loss (27.4%) (p < 0.01). | [62] |
2 | Rajkumar et al., 2007 | Open prospective controlled clinical trial | 6 months | India | Patients aged 18–60 years with hepatitis B infection | HD-03/ES(25) | HD-03/ES-2 capsules twice day for 6 months | ALT, AST, total bilirubin, serum protein | HD-03/ES showed significant reduction in ALT values from 66.5 ± 11.1 to 39.1 ± 5.2 (p < 0.01), significant HBsAg loss (52%, p < 0.001), HBeAg loss (60%, p < 0.05) and HBV DNA loss (60%, p < 0.05). | [63] |
3 | Habibullah et al., 1978 | Double-blind study | Till total biochemical recovery | India | Patients suffering from viral hepatitis | Liv.52 group (25,25); Placebo (25,25) | Liv.52-2 tabs three times daily | SGPT, ALP, serum albumin, serum globulin, serum cholesterol, prothrombin time, serum bilirubin | Compared to placebo, Liv.52 showed faster biochemical recovery (2.4 weeks in Liv.52 group versus 3.8 weeks in placebo group). | [59] |
4 | Gupta et al., 1972 | Controlled clinical study | Follow up at intervals of 15 days/one month | India | Patients of infectious hepatitis from infancy to twelve years | Liv.52 (55, ND); control (30, ND) | Liv.52-1 tablet or 10 drops three times a day (up to 2 years); 1 tablet three times a day (up to 2–5 years); 1 tablet four times a day (above 5 years) | LFT, Urine examination; Haemogram, Liver biopsy, Radiological examination | Compared with control, serum bilirubin levels, albumin/globulin ratio, SGOT, and SGPT levels were normal in Liv.52 group. Total serum protein, serum alkaline phosphatase, and prothrombin time values were not affected. Also, biopsies clearly showed receding phase of infectious hepatitis in the group treated with Liv.52 tablets. | [60] |
7 | Singh et al., 1977 | Controlled study | 8 weeks | India | Patients with infective hepatitis of varying age groups | Liv.52 (25, 25); Control (25, 25) | Liv.52-6 tablets in divided doses along with B-complex and corticosteroids daily | SGOT, SGPT, Serum bilirubin, serum alkaline phosphatase, thymol turbidity | Compared with placebo, serum bilirubin values reduced by 86%(66% in placebo). The values in the Liv.52 group after 4 weeks and 8 weeks of treatment were reduced by 23% and 42% over the initial values. The percentage decline in thymol turbidity after 4 and 8 weeks of treatment in the control group was 24% and 29% as against 37% and 66% in the Liv.52 group. SGPT and SGOT values also showed reductions. | [61] |
8 | Jha et al., 2021 | Comparative study | 18 months | India | Patients with hepatitis B | Tenofovir(35,35); Liv.52 HB (32,32); Tenofovir plus Liv.52 HB (37,37) | - | ALT, AST, Serum bilirubin, ALP, serum creatinine, HbeAg, blood urea, INR, Hb | Tenofovir plus Liv.52 group showed significant reductions in Serum Bilirubin, serum ALT, AST, and ALP levels compared to tenofovir alone or Liv52 HB alone. There was a statistically significant reduction in HbsAg after 12 months within the tenofovir + Liv52Hb group, and also the outcome was statistically better when compared to other two groups. HbeAg positivity was also significantly better in the tenofovir + Liv52 HB group in both inter and intra-group comparisons. | [75] |
Non-infectious chronic liver disease | ||||||||||
1 | Al- Khazraji et al., 2022 | Interventional randomized blind clinical trial | 6 months | Iraq | Patients with liver damage | Liv.52 (100, ND; Control (100, ND) | Liv.52-2 tablets thrice daily | ALT, AST, total serum bilirubin, ALP serum albumin | Compared to control, Liv.52 showed significant reduction in ALT (p = 0.019), AST (p = 0.231), total serum bilirubin (p = 0.148), ALP (p = 0.359), and serum albumin (p < 0.001). | [65] |
Alcoholic liver disease | ||||||||||
1 | Kalab et al., 1997 | Retrospective study | 1 year | Prague | Patients having liver damage caused by alcohol, steatosis and persistent hepatitis. | Liv.52 (19, ND) | Liv.52-2 tablets (b.i.d.) for 1 year | ALT, AST, ALP, serum bilirubin, TZR, GMT | Liv.52 showed significant reduction in ALT, AST, GMT levels. There was no influenced on the value of TZR. | [76] |
2 | De Silva et al., (84) | Prospective, double-blind, randomized, placebo-controlled trial | 6 months | Srilanka | Patients with alcoholic liver disease. | Liv.52 (40, 19); Placebo(40, 19) | Liv.52-3 capsules twice daily for 6 months | ALT and AST, gamma-GT, albumin, and bilirubin | Compared to placebo, there were no significant outcome measures observed in Liv.52 treated group. No subject complained of adverse effects attributable to the drug. | [11] |
Liver dysfunction in pregancy | ||||||||||
1 | Mitra et al., 2008 | - | 6 weeks | India | Pregnant women with severe viral hepatitis | Liv.52 (84, ND) | - | Liver biopsy | Liv.52 brought reduced the earlier reported mortality from 26.7% to 1.1% in patients of jaundice with pregnancy. All the patients recovered completely after 6 weeks of treatment except one patient. | [70] |
Liver cirrhosis | ||||||||||
1 | Huseini et al., 2004 | Randomized, double-blind, placebo-controlled | 6 months | Iran | Subjects with liver cirrhosis were selected | Placebo (18,18); Liv.52 (18,18) | Liv.52—3 tablets twice daily for 6 months | ALT, AST, Child–Pugh score, ascites | Significant reduction in ALT (Mean 89 to 38), AST values (mean from 89 to 57) along with reduction in ascites and child-pugh scores. | [37] |
Hepatomegaly syndrome | ||||||||||
1 | Marginean et al., 2002 | Open clinical trial | 6 months | Romania | Children (2–17 years) diagnosed with hepatomegaly syndrome. | Liv.52 (51,51); control (20,20) | Liv.52 syrup-2.5 mL (½ teaspoon), twice daily (children under 12 years of age); 5 mL (1 teaspoon) twice daily (children above 12 years) | AST, ALT, lactic-dehydrogenase, immunoglobulins, and serum proteins. | Compared to control, Liv.52 group showed significant decrease in AST and ALT values. Liv.52 group stimulated the synthesis of gammaglobulin. Liv.52 also improved protein synthesis. | [74] |
Sr No. | Study and Origin | Study Design | Country | Indication | Study Size (N), Duration | Intervention | Outcome Measures | Results | References |
---|---|---|---|---|---|---|---|---|---|
1 | Ganesh et al. 2022 | Review | India | Alcoholic liver disease | N = 19 to 50, upto 1 year | Liv.52 DS | Liver parameters like ALT, AST, prothrombin, clinical symptoms like ascites, USG | Improvement in liver parameters, clinical symptoms, and USG findings. | [57] |
2 | Sharad C et al., 2022 | Cumulative efficacy analysis | India | Non-alcoholic fatty liver disease | N = 35 to 50, up to 3 months | Liv.52 DS | Liver parameters like ALT, AST, clinical symptoms, USG (fatty liver grading, hepatomegaly), NAFLD fibrosis score | Improvement of hepatic parameters and clinical symptoms | [73] |
3 | Maji et al., 2013 | Review | India | Hepatitis B infection | N = 14 to 51 (up to 6 months) | Liv.52 HB | LFT paramters, HbsAg, HbeAg, HBV DNA | Improvement in LFT paramters and lss of HbsAg, HbeAg, HBV DNA | [64] |
3. Discussion
4. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Kantharia, C.; Kumar, M.; Jain, M.K.; Sharma, L.; Jain, L.; Desai, A. Hepatoprotective Effects of Liv.52 in Chronic Liver Disease Preclinical, Clinical, and Safety Evidence: A Review. Gastroenterol. Insights 2023, 14, 293-308. https://doi.org/10.3390/gastroent14030021
Kantharia C, Kumar M, Jain MK, Sharma L, Jain L, Desai A. Hepatoprotective Effects of Liv.52 in Chronic Liver Disease Preclinical, Clinical, and Safety Evidence: A Review. Gastroenterology Insights. 2023; 14(3):293-308. https://doi.org/10.3390/gastroent14030021
Chicago/Turabian StyleKantharia, Chetan, Munesh Kumar, Mukesh Kumar Jain, Lokendra Sharma, Lokesh Jain, and Anish Desai. 2023. "Hepatoprotective Effects of Liv.52 in Chronic Liver Disease Preclinical, Clinical, and Safety Evidence: A Review" Gastroenterology Insights 14, no. 3: 293-308. https://doi.org/10.3390/gastroent14030021