The clinical assessment appeared this month in Advances in Integrative Medicine, reporting the safety and tolerability of 480 milligrams of Shoden standardized to 35% withanolide glycosides in 62 healthy volunteers for 90 days.
According to the India-based supplier of botanical extracts, these human clinical findings address a critical gap in the supplement industry, “where efficacy claims often outpace rigorous safety documentation”. The company has published 150 peer-reviewed scientific articles in its 35-year history and acknowledged the limited availability of safety data on ashwagandha root-leaf combination extracts.
“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 publication of the study, led by researchers at Arjuna Natural, comes amid growing scientific and regulatory scrutiny of ashwagandha extracts following a rare signal of idiosyncratic liver injury associated with some ashwagandha products, and a public discourse of the safety of root-only vs. root-leaf combination products.
Underscoring the rigor of the methodology
Arjuna highlights its rigorous clinical methodology, monitoring participants—32 men and 30 women between the ages of 18 and 55—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, the researchers reported that all monitored parameters remained within normal physiological ranges, with no statistically significant deviations from baseline values observed at any time point.
These parameters included hepatic and renal function markers, as well as urine analysis. Blood glucose levels, serum cholesterol concentrations, body weight, blood pressure and heart rate likewise remained within normal ranges, with no significant changes observed over the course of the study. Erythrocyte sedimentation rate, a sensitive marker of systemic inflammation, showed no evidence of an inflammatory response to the intervention.
The researchers noted that these findings establish a foundation for further research to explore the relationship between dose, bioavailability and possible health benefits and acknowledged the need for additional safety studies.
“It is also noteworthy that future large-scale, controlled studies need to expand their longitudinal monitoring framework at least to six months or longer to specifically identify and screen delayed-onset symptoms and cumulative toxicity risk, so as to establish a long-term safety paradigm for highly standardized ashwagandha extracts” they wrote.
Positioning scientific rigor and concentration as differentiator
Arjuna contrasts its transparency with what it describes as competitors’ reliance on unpublished proprietary studies or marketing literature lacking external scientific review.
“Publishing safety data creates accountability,” Dr. Benny said. “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.”
The safety validation joins a portfolio of 11 peer-reviewed clinical trials investigating Shoden’s efficacy across stress resilience, sleep quality, cognitive performance and hormonal balance. With safety validated, the Arjuna research team also took the opportunity to emphasize potential advantages of using its standardized root-leaf extract.
“Unlike previous studies that primarily examined the impact and efficiency of ashwagandha using root extracts with low withanolide content of 1.5–5%, this study uses a highly standardized ashwagandha extract (35% withanolide glycosides), derived from its roots and leaf combination, which reportedly aids in enhanced bioavailability,” they wrote.
According to Arjuna, Shoden’s 35% withanolide glycoside standardization represents the highest concentration achieved in any commercialized ashwagandha extract globally, which it says demonstrates therapeutic efficacy at low doses of 60 to 120 mg/day compared to competitor products requiring 300 to 600 mg. It also stated that Shoden’s withanolide compounds remain bioavailable in systemic circulation for 24 hours, enabling once-daily dosing regimens to improve patient compliance.
“When botanical ingredients are properly extracted, appropriately standardized and rigorously validated through clinical research, they deliver therapeutic benefits matched by exceptional safety profiles,” said Benny Antony, co-founder and managing director at Arjuna Natural. “Shoden exemplifies the proposition that efficacy and safety are not mutually exclusive.”
Source: Advances in Integrative Medicine. doi: 10.1016/j.aimed.2026.100688. “Safety and tolerability assessment of Shoden, the Ashwagandha extract standardised with withanolide glycosides: An open label study in healthy volunteers.” Authors: Benny et al.
