Research Article Safety Evaluation of Standardized Extract of Curcuma longa (NR- INF-02): A 90-Day Subchronic Oral Toxicity Study in Rats Sasikumar Murugan, 1 Himanshu Solanki, 2 Divya Purusothaman, 1 Bharathi Bethapudi , 1 Mital Ravalji, 2 and Deepak Mundkinajeddu 1 1 R&D Center, Natural Remedies Private Limited, Bengaluru, Karnataka, India 2 Sa-FORD, Navi Mumbai, Maharashtra, India Correspondence should be addressed to Bharathi Bethapudi; bharathi.b@naturalremedy.com Received 13 November 2020; Accepted 19 June 2021; Published 14 July 2021 Academic Editor: Elena Baralla Copyright © 2021 Sasikumar Murugan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. NR-INF-02 is a standardized extract containing turmerosaccharides from Curcuma longa that has anti-inflammatory, analgesic, and chondroprotective potential. In view of its potential uses, NR-INF-02 was evaluated for its safety in Wistar rats at an oral dose of 250, 500, and 1000 mg/kg in a 90-day repeated dose subchronic toxicity study. NR-INF-02 administered at 250, 500, and 1000 mg/kg for 90 days did not show any mortality or clinical signs of toxicity. Body weight gain, food consumption, ocular and neurological examination, and hematological, blood biochemical, hormone, and urine analysis revealed no evidence of toxicity of NR-INF-02 treatment in rats. Absolute and relative organ weights were comparable to control rats. The study did not reveal any major treatment related gross pathological and histopathological alterations in the tissues or organs examined. Thus, based on study observations, the no-observed adverse effect level (NOAEL) was found to be 1000 mg/kg body weight in albino Wistar rats. 1. Introduction Herbal remedy usage is rapidly growing all over the world. In addition, there is growing inclination towards proprietary herbal remedies that are efficacious than regular extracts. However, the safety of the proprietary extracts cannot be relied on its herbal source. Not all the natural treatments are safe and free of adverse effects. Though the efficacy of the herbal remedies is being evinced through conventional experimental methodology, the safety reports of the formula- tions remain inadequate and meager. The toxicological investigations have to be intensified in compliance with internationally acceptable guideline of safety and toxicity study [1]. A well-known herb Curcuma longa of the Zingiberaceae family is native to South and Southeast Asia. It is called as “golden spice” of India. C. longa has been reported in Ayur- veda, an Indian traditional system of medicine for its effects on wound healing, nausea, indigestion, inflammation, and liver diseases and improving skin complexion. In addition, C. longa is extensively researched for fever alleviation and antitumor, antimutagenic, antioxidant, anti-inflammatory, antidiabetic, and other pharmacological effects [2–6]. Most of the effects of C. longa have been attributed to curcumi- noids. However, the minimally explored aqueous extract of C. longa was also found to possess antitumor [7], antidiabetic [8], antimicrobial [9], hepatoprotective [10], fertility- enhancing [11], antidepressant [12], antioxidant [13], anti- bacterial, and immunomodulatory activities [14]. In the current study, the safety of one such extract, NR-INF-02, developed using a patented aqueous-based process was investigated. NR-INF-02 is a proprietary extract with negligi- ble amount of curcuminoids and is rich in turmerosacchar- ides. NR-INF-02 is well established as an analgesic [15], anti-inflammatory [16, 17], and antiosteoarthritic agent [15, 18, 19]. NR-INF-02 attenuated the release of chondrocyte- degrading markers like IL-6, IL-8, COX-2, PGE2, tumor necrosis factor-alpha (TNF-α), and intercellular adhesion molecule- (ICAM-) 1 in IL-1β-treated human knee articular chondrocytes (NHAC-kn). Also, NR-INF-02 protected IL- Hindawi BioMed Research International Volume 2021, Article ID 6671853, 14 pages https://doi.org/10.1155/2021/6671853