Safety assessment of selected medicinal food plants used in Ayurveda through CYP450 enzyme inhibition study

Kar, Amit; Pandit, Subrata; Mukherjee, Kakali; Bahadur, Shiv

doi:10.1002/jsfa.7739

Cited by 19 publications

(11 citation statements)

References 18 publications

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“…As for the safety of C. asiatica extract, clinical trials have shown that 250 mg and 500 mg of standard extract were well tolerated in single and multiple oral doses. Modern pharmacological tests showed that the interaction potential of C. asiatica biologically active compounds with CYP isoenzymes is negligible, and the heavy metal content in the extract is within the allowable range (Kar et al, 2017). Animal experiments have found that C. asiatica extract has anti-spermogenic and anti-fertility effects on the reproductive system of male rats (Yunianto et al, 2010).…”

Section: Safety and Toxicity Of C Asiaticamentioning

confidence: 99%

Therapeutic Potential of Centella asiatica and Its Triterpenes: A Review

Sun

et al. 2020

Front. Pharmacol.

190

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Centella asiatica (also known as Centella asiatica (L.) Urb. or Gotu kola) is a traditional Chinese medicine with extensive medicinal value, which is commonly used in Southeast Asian countries. This study aimed to summarize the effects of C. asiatica and its main components on neurological diseases, endocrine diseases, skin diseases, cardiovascular diseases, gastrointestinal diseases, immune diseases, and gynecological diseases, as well as potential molecular mechanisms, to study the pathological mechanism of these diseases based on the changes at the molecular level. The results showed that C. asiatica and its triterpenoids had extensive beneficial effects on neurological and skin diseases, which were confirmed through clinical studies. They exhibited anti-inflammatory, antioxidative stress, anti-apoptotic effects, and improvement in mitochondrial function. However, further clinical studies are urgently required due to the low level of evidence and lack of patients.

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Section: Safety and Toxicity Of C Asiaticamentioning

confidence: 99%

Therapeutic Potential of Centella asiatica and Its Triterpenes: A Review

Sun

et al. 2020

Front. Pharmacol.

190

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“…However, the relevance of this evidence to CAW was complicated by the large variability in the type of CA preparations that are used in dietary supplements, as well as in those used in earlier preclinical and clinical studies (19). For example, although previous studies had examined the effects of CA extracts on CYP drug metabolizing enzymes (63)(64)(65)(66)(67), the FDA recommended that we examine and report the drug interaction potential of our CAW water extract specifically (68). Also, since earlier preclinical studies on organ toxicity had been performed using other types of CA extracts (69-72), we obtained organ toxicity data from mice treated with CAW that could be used in the IND application.…”

Section: Regulatory Aspectsmentioning

confidence: 99%

Developing a Rational, Optimized Product of Centella asiatica for Examination in Clinical Trials: Real World Challenges

et al. 2022

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Botanical products are frequently sold as dietary supplements and their use by the public is increasing in popularity. However, scientific evaluation of their medicinal benefits presents unique challenges due to their chemical complexity, inherent variability, and the involvement of multiple active components and biological targets. Translation away from preclinical models, and developing an optimized, reproducible botanical product for use in clinical trials, presents particular challenges for phytotherapeutic agents compared to single chemical entities. Common deficiencies noted in clinical trials of botanical products include limited characterization of the product tested, inadequate placebo control, and lack of rationale for the type of product tested, dose used, outcome measures or even the study population. Our group has focused on the botanical Centella asiatica due to its reputation for enhancing cognition in Eastern traditional medicine systems. Our preclinical studies on a Centella asiatica water extract (CAW) and its bioactive components strongly support its potential as a phytotherapeutic agent for cognitive decline in aging and Alzheimer's disease through influences on antioxidant response, mitochondrial activity, and synaptic density. Here we describe our robust, scientific approach toward developing a rational phytotherapeutic product based on Centella asiatica for human investigation, addressing multiple factors to optimize its valid clinical evaluation. Specific aspects covered include approaches to identifying an optimal dose range for clinical assessment, design and composition of a dosage form and matching placebo, sourcing appropriate botanical raw material for product manufacture (including the evaluation of active compounds and contaminants), and up-scaling of laboratory extraction methods to available current Good Manufacturing Practice (cGMP) certified industrial facilities. We also address the process of obtaining regulatory approvals to proceed with clinical trials. Our study highlights the complexity of translational research on botanicals and the importance of identifying active compounds and developing sound analytical and bioanalytical methods for their determination in botanical materials and biological samples. Recent Phase I pharmacokinetic studies of our Centella asiatica product in humans (NCT03929250, NCT03937908) have highlighted additional challenges associated with designing botanical bioavailability studies, including specific dietary considerations that need to be considered.

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“…C. asiatica standard extract at doses of 250 and 500 mg was found to be well tolerated in human subjects administered orally in single and multiple doses. CYP450 enzyme inhibition study and heavy metal content analysis revealed its safe use as a medicinal food plant (Kar, Pandit, Mukherjee, Bahadur, & Mukherjee, 2017). Chronic use of this plant extract in healing wounds caused skin irritation and contact dermatitis in some cases (Bilbao et al, 1995).…”

Section: Toxicity Studiesmentioning

confidence: 99%

Ethnobotany, phytochemistry, pharmacology, and toxicity of Centella asiatica (L.) Urban: A comprehensive review

Biswas

Mandal

Saha

et al. 2021

Phytotherapy Research

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The medicinal plant C. asiatica (L.) Urban, belongs to the family Apiaceae, commonly known as "Pennywort." It is a perennial herb, normally grows in temperate and tropical wetlands. It consists of slender stems; creeping stolons; petiolate, stalked, and rounded leaves with palmately netted veins; pinkish, bisexual flowers and hairy, vertical, rhizomatous rootstock (S. Singh, Gautam, Sharma, & Batra, 2010).It is a slightly aromatic, herbaceous, stoloniferous, prostrate creeper of 12-15 cm in average height. Stem is rounded, glabrous, striated with rooting nodes. Leaves are 2-6 cm Â 1.5-5 cm in size, orbicularrenniform, glabrous, long petiolate with crenate margin, and sheathing leaf bases. Pinkish white to purple flowers are arranged in facicled umbels. Oblong shaped fruits are approximately 2 inches long with thickened pericarps and having seeds with the laterally compressed pendulous embryo (Prasad et al., 2014; S. Singh et al.). Habit and some morphological features of C. asiatica are presented in Figure 1. Taxonomic hierarchy of C. asiatica (L.

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Safety assessment of selected medicinal food plants used in Ayurveda through CYP450 enzyme inhibition study

Abstract: The findings suggested that selected food plants and bioactive compounds contributed negligible interaction potential with CYP isozymes and may not possess any harmful effect with regard to their therapeutic application. © 2016 Society of Chemical Industry.

Cited by 19 publications

References 18 publications

Therapeutic Potential of Centella asiatica and Its Triterpenes: A Review

Therapeutic Potential of Centella asiatica and Its Triterpenes: A Review

Developing a Rational, Optimized Product of Centella asiatica for Examination in Clinical Trials: Real World Challenges

Ethnobotany, phytochemistry, pharmacology, and toxicity of Centella asiatica (L.) Urban: A comprehensive review

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