Patented Ashwagandha root and leaf extract
A comprehensive clinical assessment published in Advances in Integrative Medicine confirms zero adverse effects at therapeutic doses. KOCHI, India – September 1, 2026 – Arjuna Natural Pvt. Ltd. announced today the publication of a comprehensive clinical safety assessment of Shoden®, its proprietary Ashwagandha extract standardized to 35% withanolide glycosides, in the peer-reviewed journal Advances in Integrative Medicine. The study, conducted across 62 healthy volunteers over 90 consecutive days, provides scientific validation that daily administration of 480 milligrams of Shoden® is safe and well-tolerated, with no clinically significant adverse effects observed. The research represents a significant milestone in evidence-based botanical supplementation, further establishing Shoden® as a safe, highly bioavailable, and clinically validated ashwagandha root and leaf extract. These human clinical findings address a critical gap in the supplement industry, where efficacy claims often outpace rigorous safety documentation. “This peer-reviewed safety study reflects Arjuna Natural’s unwavering commitment to rigorous botanical science,” said Dr. Iwin Joseph Benny, lead researcher and Clinician at Arjuna Natural. “Healthcare practitioners can now recommend Shoden® with absolute confidence that the ingredient is not only therapeutically active but exceptionally safe for sustained use.” The study employed rigorous clinical methodology, monitoring participants through four assessment points spanning the 90-day period. Comprehensive biochemical and hematological panels evaluated hepatic function, renal clearance, metabolic parameters, and systemic inflammatory markers. Throughout the trial, all monitored parameters remained within normal physiological ranges, with no statistically significant deviations from baseline values observed at any time point. Hepatic function markers—including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin—remained stable throughout the trial, demonstrating that Shoden® administration imposes no hepatic metabolic burden. This carries clinical significance for patients with compromised liver function or those using other therapeutics metabolized through hepatic pathways. Renal function assessment proved equally reassuring. Glomerular filtration rate measurements remained stable throughout the 90-day period, consistently tracking at or above age-specific physiological norms. Urine analysis revealed no qualitative abnormalities, indicating the absence of renal stress. Blood glucose levels, serum cholesterol concentrations, body weight, blood pressure, and heart rate all remained within normal ranges with no significant variability. Erythrocyte sedimentation rate, a sensitive marker of systemic inflammation, remained normal, indicating that 90 days of Shoden® administration did not elicit an inflammatory response. The complete absence of clinically significant adverse effects distinguishes Shoden® within the botanical supplement landscape, where herbal products frequently generate reports of gastrointestinal disturbances, headaches, or allergic reactivity. This safety validation builds upon Arjuna Natural’s expanding body of clinical evidence. The company has published 11 peer-reviewed clinical trials demonstrating Shoden®’s efficacy across stress resilience, sleep quality, cognitive performance, and hormonal balance domains. Shoden®’s 35% withanolide glycoside standardization represents the highest concentration achieved in any commercialized ashwagandha extract globally, substantially exceeding the 4 to 7 percent standardization typical of competitors. Clinical data demonstrates therapeutic efficacy at low doses—60 to 120 milligrams daily—compared to competitor products requiring 300 to 600 milligrams. Additionally, Shoden’s withanolide compounds remain bioavailable in systemic circulation for 24 hours following administration, enabling once-daily dosing regimens that substantially improve patient compliance. Furthermore, the ingredient maintains Health Canada Natural and Non-prescription Health Products Directorate approval for multiple health claims, including stress and sleep support. “From a manufacturer’s perspective, Shoden® represents a rare combination of competitive differentiation and regulatory defensibility,” noted Benny Antony, Co-Founder and Managing Director at Arjuna Natural. “The ingredient enables supplement and food brands to make substantiated health claims while simultaneously providing unprecedented liability protection and regulatory confidence.” Publication of this safety study in Advances in Integrative Medicine subjects Shoden® to the scientific scrutiny and editorial standards applied to all published research. The open-access publication model ensures that healthcare practitioners, researchers, and consumers can independently access and evaluate the complete study methodology, findings, and conclusions. This transparency contrasts sharply with competitors’ reliance on unpublished proprietary studies or marketing literature lacking external scientific review. “Publishing safety data creates accountability,” Dr. Benny explained. “If competitors wish to challenge these findings, they must do so through peer-reviewed literature rather than unsubstantiated marketing claims. This scientific rigor ultimately protects consumers and healthcare practitioners by establishing evidence-based standards for the adaptogenic supplement category.” “When botanical ingredients are properly extracted, appropriately standardized, and rigorously validated through clinical research, they deliver therapeutic benefits matched by exceptional safety profiles,” Antony concluded. “Shoden® exemplifies the proposition that efficacy and safety are not mutually exclusive.” The published article, “Safety and tolerability assessment of Shoden, the Ashwagandha extract standardised with withanolide glycosides: An open label study in healthy volunteers,” appears in Advances in Integrative Medicine, Volume 13, 2026. The open-access publication is available at www.sciencedirect.com/journal/advances-in-integrative-medicine, with digital object identifier https://doi.org/10.1016/j.aimed.2026.100688. About Arjuna Natural Arjuna Natural is an innovator in clinically validated botanical extracts serving the global nutraceutical, pharmaceutical, and functional food industries. The company combines 35 years of botanical science expertise with contemporary extraction methodologies and rigorous clinical validation. Arjuna Natural has published 150 peer-reviewed scientific articles, maintains 120 international patents, and operates state-of-the-art manufacturing facilities powered entirely by renewable energy.
