Arjuna Natural's ashwagandha extract receives peer-reviewed validation for safety and tolerability

A comprehensive clinical assessment published in Advances in Integrative Medicine confirms zero adverse effects at therapeutic doses

Arjuna Natural has announced the publication of a comprehensive clinical safety assessment of Shoden, its proprietary Ashwagandha extract standardised 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 metabolised through hepatic pathways.

The company has published 11 peer-reviewed clinical trials demonstrating Shoden's efficacy across stress resilience, sleep quality, cognitive performance, and hormonal balance domains

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 qualitativevabnormalities, 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 standardisation 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. 

The open-access publication is available HERE, with the following digital object identifier: https://doi.org/10.1016/j.aimed.2026.100688.

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