Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 May 20;10(1):FSO910.
doi: 10.2144/fsoa-2023-0118. eCollection 2024.

Acute and sub-chronic toxicity study of novel polyherbal formulation in non-alcoholic fatty liver using Wistar rats

Anuragh Singh  1 , K Ilango  2
Affiliations

Acute and sub-chronic toxicity study of novel polyherbal formulation in non-alcoholic fatty liver using Wistar rats

Anuragh Singh et al. Future Sci OA. .

Abstract

Aim: This study assessed the acute and sub-chronic toxicity of a novel polyherbal formulation tablet in Wistar rats Materials & methods: Acute toxicity and sub-chronic toxicity was assessed following OECD (Organisation for the Economic Co-operation and Development) guidelines based on 423 and 408. Results & conclusion: No mortality and toxicity showed in rats during acute toxicity. The LD50 of the extract was at 2000 mg/kg. In sub-chronic study, both sex rats were orally administered at 250, 500,1000 and 2000 mg/kg for 90 days and revealed no significant difference (p < 0.05) in hematological and other parameters compared with the control. Histopathology study did not reveal morphological alteration. The No observed adverse effect level of the tablet was observed until 2000 mg/kg.

Keywords: NOAEL; PHF tablet; acute toxicity; non-alcoholic fatty liver; sub-chronic toxicity.

Plain language summary

Non-alcoholic fatty liver disease (NAFLD) affects around 25% of individuals globally and has become the most common long-term liver problem. The reasons why people get this disease can be different for each person. By studying natural substances, scientists have discovered that some compounds help treat the disease some of these substances can also be harmful. By studying natural substances, scientists have discovered that some compounds help treat the disease some of these substances can also be harmful. People are also trying out traditional medicines more and more, and we need to make sure they're safe. To determine whether a medication is secure, we conducted experiments in accordance with the OECD guidelines. One test examines whether a high dose of the drug is lethal. The goal is to determine the optimal dose, which is neither too low nor too excessive. Another test investigated what happens if these rats take the medicine every day for a long time. Variables such as blood tests and tissue samples are collected to make sure the medicine does not make the rats sick. In this case, we tested a medicine called a ‘PHF tablet’ for 90 days, and it didn't make the animals sick. They found that you can take a relatively high dose without any adverse effects.

PubMed Disclaimer

Conflict of interest statement

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

Figure 1.
Figure 1.
Acute body weight of female rats monitored for up to 14 days per OECD guidelines 423, showing no significant difference from start to end of the study.
Figure 2.
Figure 2.
Body weight variation in males from a period of 0th week to 13th weeks after the dosage of PHF tablet. Body weight variation in females from period of 0th week to 13th weeks after the dosage of PHF tablet.
Figure 3.
Figure 3.
Food intake variation in males from period of 0th week to 13th weeks after the dosage of PHF tablet. Food intake variation in females from period of 0th week to 13th weeks after the dosage of PHF tablet. Mean absolute organ weight in males after dosage of PHF tablet. Mean absolute organ weight variation in females after dosage of PHF tablet.
Figure 4.
Figure 4.
Represent the micrograph of the various vital organs from the control group.
Figure 5.
Figure 5.
Represent the micrograph of the various vital organs from the group consuming 250 mg/kg of PHF tablet.
Figure 6.
Figure 6.
Represent the micrograph of the various vital organs from the group consuming 500 mg/kg of PHF tablet.
Figure 7.
Figure 7.
Represent the micrograph of the various vital organs from the group consuming 1000 mg/kg of PHF tablet.
Figure 8.
Figure 8.
Represent the micrograph of the various vital organs from the group consuming 2000 mg/kg of PHF tablet.
Figure 9.
Figure 9.
Lox enzyme levels observed in LPS alone, Diclofenac with different concentrations treatment on LPS-induced Raw 264.7 cells after the incubation period of 24 h. Each assay was performed in duplicate and the experiments were repeated once.
Figure 10.
Figure 10.
Lox enzyme levels observed in LPS alone, tablet with different concentrations treatment on LPS-induced Raw 264.7 cells after the incubation period of 24 h. Each assay was performed in duplicate and the experiments were repeated once.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease—meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology 64(1), 73–84 (2016). - PubMed
    1. Younossi Z, Anstee QM, Marietti Met al. . Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nature reviews Gastroenterology & hepatology. 15(1), 11–20 (2018). - PubMed
    1. Angulo P, Kleiner DE, Dam-Larsen Set al. . Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology 149(2), 389–397.e310 (2015). - PMC - PubMed

    2. •• This article is of considerable interest, as it denotes about the histologic features and the outcome of the fibrosis in NAFLD patient.

    1. Fan J-G, Kim S-U, Wong VW-S. New trends on obesity and NAFLD in Asia. J. Hepatol. 67(4), 862–873 (2017). - PubMed

    2. • This article is of interest, as it denotes about the trends of obesity, NAFLD and NASH in Asia. The Asian patients are however, under presented in any of the clinical trials as this disease remain very uncommon in Asian population.

    1. Lambert JE, Ramos–Roman MA, Browning JD, Parks EJ. Increased de novo lipogenesis is a distinct characteristic of individuals with nonalcoholic fatty liver disease. Gastroenterology 146(3), 726–735 (2014). - PMC - PubMed

    2. •• This article is of considerable interest, as it denotes about the NAFLD patients who had higher nocturnal plasma levels of FFAs and did not suppress the contribution from de novo lipogenesis on fasting.