OECD-407 Driven 28-day-repeated-dose non-clinical safety evaluation of <i>Tinospora cordifolia</i> (Giloy) stem aqueous extract in Sprague-Dawley rats under GLP compliance

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Abstract

Introduction: Tinospora cordifolia (Wild.) Hook.f. & Thomson (Giloy), has been widely used in the Ayurvedic system of medicine. However, some sporadic under-powered case studies have recently reported Tinospora cordifolia associated toxicity. Thus, following OECD 407 guidelines, a 28-day-repeated-dose-14-day-recovery toxicological evaluation of the aqueous extract of T. cordifolia stem (TCWE) was conducted under good laboratory practice (GLP), in Sprague-Dawley (SD) rats.

Methods: 100, 300, and 1000 mg/kg/day of TCWE was given orally to designated treatment groups of either sex. Two separate 14-day recovery satellite groups received either vehicle control or 1000 mg/kg/day of TCWE.

Results: In this study, TCWE was found safe up to a dose of 1000 mg/kg/day with no mortality or related toxicological manifestation in terms of clinical signs, ocular effects, hematology, urinalysis, clinical chemistry parameters, or macro- or microscopic changes in any organs. The satellite group did not show any adverse effect after 14-day recovery period. Thus, the No-Observed-Adverse-Effect-Level (NOAEL) of TCWE was determined to be 1000 mg/kg/day.

Discussion: In conclusion, this study established the non-clinical safety of the aqueous extract of T. cordifolia stem, which confirms the age-old safe medicinal use of this herb, and also paves the path for future clinical research on formulations containing Tinospora cordifolia.

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Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0

Nathalie Percie Du Sert, Amrita Ahluwalia, Sabina Alam … (2020)

Improving the reproducibility of biomedical research is a major challenge. Transparent and accurate reporting is vital to this process; it allows readers to assess the reliability of the findings and repeat or build upon the work of other researchers. The ARRIVE guidelines (Animal Research: Reporting In Vivo Experiments) were developed in 2010 to help authors and journals identify the minimum information necessary to report in publications describing in vivo experiments. Despite widespread endorsement by the scientific community, the impact of ARRIVE on the transparency of reporting in animal research publications has been limited. We have revised the ARRIVE guidelines to update them and facilitate their use in practice. The revised guidelines are published alongside this paper. This explanation and elaboration document was developed as part of the revision. It provides further information about each of the 21 items in ARRIVE 2.0, including the rationale and supporting evidence for their inclusion in the guidelines, elaboration of details to report, and examples of good reporting from the published literature. This document also covers advice and best practice in the design and conduct of animal studies to support researchers in improving standards from the start of the experimental design process through to publication.

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Tinospora cordifolia: One plant, many roles

Soham Saha, Shyamasree Ghosh (2012)

Natural products with medicinal value are gradually gaining importance in clinical research due to their well-known property of no side effects as compared to drugs. Tinospora cordifolia commonly named as “Guduchi” is known for its immense application in the treatment of various diseases in the traditional ayurvedic literature. Recently the discovery of active components from the plant and their biological function in disease control has led to active interest in the plant across the globe. Our present study in this review encompasses (i) the genetic diversity of the plant and (ii) active components isolated from the plant and their biological role in disease targeting. The future scope of the review remains in exploiting the biochemical and signaling pathways affected by the compounds isolated from Tinospora so as to enable new and effective formulation in disease eradication.

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Tinospora cordifolia (Willd.) Hook. f. and Thoms. (Guduchi) – validation of the Ayurvedic pharmacology through experimental and clinical studies

Avnish Upadhyay, Kaushal Kumar, Arvind Kumar … (2010)

T. cordifolia (Guduchi) is a large, glabrous, perennial, deciduous, climbing shrub of weak and fleshy stem found throughout India. It is a widely used plant in folk and Ayurvedic systems of medicine. The chemical constituents reported from this shrub belong to different classes, such as alkaloids, diterpenoid lactones, glycosides, steroids, sesquiterpenoid, phenolics, aliphatic compounds and polysaccharides. Various properties of T. cordifolia, described in ancient texts of Ayurveda, like Rasayana, Sangrahi, Balya, Agnideepana, Tridoshshamaka, Dahnashaka, Mehnashaka, Kasa-swasahara, Pandunashaka, Kamla-Kushta-Vataraktanashaka, Jwarhara, Krimihara, Prameha, Arshnashaka, Kricch-Hridroganashak, etc., are acquiring scientific validity through modern research adopting "reverse pharmacological" approach. Potential medicinal properties reported by scientific research include anti-diabetic, antipyretic, antispasmodic, anti-inflammatory, anti-arthritic, antioxidant, anti-allergic, anti-stress, anti-leprotic, antimalarial, hepato-protective, immuno-modulatory and anti-neoplastic activities. This review brings together various properties and medicinal uses of T. cordifolia described in Ayurveda, along with phytochemical and pharmacological reports.

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Author and article information

Contributors

Swati Haldar: URI : https://loop.frontiersin.org/people/1451326/overview

Anurag Varshney: URI : https://loop.frontiersin.org/people/601884/overview

Journal

Journal ID (nlm-ta): Front Pharmacol

Journal ID (iso-abbrev): Front Pharmacol

Journal ID (publisher-id): Front. Pharmacol.

Title: Frontiers in Pharmacology

Publisher: Frontiers Media S.A.

ISSN (Electronic): 1663-9812

Publication date (Electronic): 18 May 2023

Publication date Collection: 2023

Volume: 14

Electronic Location Identifier: 1095083

Affiliations

[1] ¹ Drug Discovery and Development Division , Patanjali Research Institute , Governed by Patanjali Research Foundation Trust , Haridwar, Uttarakhand, India

[2] ² Department of Allied and Applied Sciences , University of Patanjali , Haridwar, Uttarakhand, India

[3] ³ Patanjali UK Trust , Glasgow, United Kingdom

[4] ⁴ Special Centre for Systems Medicine , Jawaharlal Nehru University , New Delhi, India

Author notes

Edited by: Chiagoziem Otuechere, Redeemer’s University, Nigeria

Reviewed by: Naibedya Chattopadhyay, Central Drug Research Institute (CSIR), India

Subhadip Banerjee, Mae Fah Luang University, Thailand

*Correspondence: Anurag Varshney, anurag@ 123456patanjali.res.in

[ † ]

Present address: Swati Haldar, Department of Genetics, Albert Einstein College of Medicine, Bronx, New York, United States

Article

Publisher ID: 1095083

DOI: 10.3389/fphar.2023.1095083

PMC ID: 10233126

PubMed ID: 37274116

SO-VID: d0c51178-df74-466a-a569-9fc5fc7b9386

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 10 November 2022

Date accepted : 11 April 2023

Funding

This research received no external funding. This presented work has been conducted using internal research funds from Patanjali Research Foundation Trust, Haridwar, India.