Acute, subchronic toxicity and genotoxicity studies of JointAlive, a traditional Chinese medicine formulation for knee osteoarthritis

Yuanyuan Wang; Li Li; Yanling Mu; Shanglong Wang; Xin Li; Jiancheng Zong; Shengcan Zou; Zimin Liu; Dehai Gao

doi:10.1371/journal.pone.0292937

Acute, subchronic toxicity and genotoxicity studies of JointAlive, a traditional Chinese medicine formulation for knee osteoarthritis

PLoS One. 2023 Oct 17;18(10):e0292937. doi: 10.1371/journal.pone.0292937. eCollection 2023.

Authors

Yuanyuan Wang¹, Li Li¹, Yanling Mu², Shanglong Wang¹, Xin Li³, Jiancheng Zong³, Shengcan Zou³, Zimin Liu¹, Dehai Gao²

Affiliations

¹ Chenland Nutritionals, Inc., Irvine, California, United States of America.
² School of Pharmacy and Pharmaceutical Sciences, Shandong First Medical University, Jinan, Shandong, China.
³ Chenland Research Institute, Qingdao City, Shandong Province, China.

Abstract

Aim: In vivo and in vitro toxicity tests of JointAlive® were studied in animal models to support the safe use of JointAlive® as a drug for knee osteoarthritis treatment.

Methods: The acute toxicity study in Sprague Dawley (SD) rats was conducted at a 20 g/kg bw/day dose of JointAlive®. For 13-week subchronic toxicity tests, SD rats were orally dosed daily with 0.5, 1.5 and 5 g/kg bw/day of JointAlive®. To assess the potential genotoxicity, Ames test, cellular chromosome aberration and mouse micronucleus test in vivo were carried out.

Results: Based on a lack of notable findings other than histopathology finding of co-incidental prostate inflammation at the high dose, the "No Observed Adverse Effect Level (NOAEL)" of JointAlive® was concluded as 5 g/kg bw/day in males and females. Results also indicated that JointAlive® has no risk of genotoxicity.

Conclusions: General toxicity and genotoxicity studies empirically demonstrated that JointAlive® poses a low risk of potential health risks, providing safety supports for the application of JointAlive® as a potential drug candidate to treat knee osteoarthritis.

Copyright: © 2023 Wang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Animals
Biological Products*
Female
Male
Medicine, Chinese Traditional
Mice
Micronucleus Tests
Mutagenicity Tests / methods
Osteoarthritis, Knee* / drug therapy
Plant Extracts
Rats
Rats, Sprague-Dawley
Toxicity Tests, Acute

Substances

Biological Products
Plant Extracts

Grants and funding

This work was supported by a grant from the Academic promotion program of Shandong First Medical University in 2019 (No.2019LJ003). This work was also funded by company Chenland Nutritionals, Inc. The funder of Chenland Nutritionals, Inc provided support in the form of salaries for authors [YW, LL, SW, XL, JZ, SZ, ZL], and also provided support in study design and preparation, data collection and analysis, decision to publish, or preparation of the manuscript. The funder of grant No.2019LJ003 provided support in the preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.