New Safety Data Add Long-Duration Evidence for a High-Concentration Ashwagandha Extract

Arjuna Natural has published a peer-reviewed safety and tolerability assessment of Shoden, its ashwagandha extract standardized to 35% withanolide glycosides, in Advances in Integrative Medicine.¹

The open-label study followed 62 healthy volunteers taking 480 mg of the extract daily for 90 consecutive days, tracking liver enzymes, kidney function, blood glucose, lipids, and inflammatory markers at 4 points across the trial period.

"This peer-reviewed safety study reflects Arjuna Natural's unwavering commitment to rigorous botanical science," noted Dr. Iwin Joseph Benny, lead researcher and clinician at Arjuna Natural, in the company's announcement.² For finished-product manufacturers formulating with ashwagandha, the study adds a longer-duration data point to a research base that has historically leaned more heavily on efficacy trials than on extended safety monitoring.

What Did the Safety Study Find, and How Was It Designed?

The trial was an open-label study, meaning all participants knowingly received the active extract and there was no placebo comparison group, a design suited to monitoring safety signals over time but not to establishing efficacy. Researchers tracked hepatic, renal, metabolic, and inflammatory parameters at baseline and at three subsequent intervals during the 90-day dosing period.

The company reports that markers of liver metabolism and kidney clearance stayed stable throughout, and that erythrocyte sedimentation rate, a general marker of systemic inflammation, showed no elevation, which the company frames as evidence the extract did not provoke an inflammatory response.¹^,2

Why Does Long-Duration Safety Data Matter for Ashwagandha Formulators?

Ashwagandha has become one of the most widely used adaptogenic botanicals in the supplement category, and a substantial share of the published clinical literature on it addresses stress, sleep, or cognitive outcomes over shorter trial periods rather than extended safety monitoring.³

A 2023 systematic review and meta-analysis of adaptogenic herbs found meaningful reductions in cortisol and perceived stress with Withania somnifera extracts, but noted that safety reporting across the reviewed trials was inconsistent in both duration and the panel of clinical markers tracked.³

Manufacturers building finished products intended for daily, sustained use have a direct interest in safety data that extends beyond the 8 to 12-week windows common in efficacy trials, since regulatory and liability exposure tends to track with duration and dose of actual consumer use rather than with trial length alone.

How Does This Fit Into the Broader Regulatory Picture for Ashwagandha Ingredients?

Ashwagandha ingredients that meet Health Canada's monograph criteria can carry authorized stress- and sleep-related claims in that market, a pathway that requires submission of supporting safety and efficacy data to the Natural and Non-prescription Health Products Directorate.⁴

In the United States, ashwagandha remains regulated as a dietary ingredient without a comparable premarket claims-authorization process, meaning structure/function claims fall to each manufacturer's own substantiation file.

"From a manufacturer's perspective, Shoden represents a rare combination of competitive differentiation and regulatory defensibility," said Benny Antony, co-founder and managing director at Arjuna Natural, in the announcement.

What Are the Limitations of This Study?

The study's open-label design and lack of a placebo arm limit what can be concluded about causality, since it cannot rule out that observed stability in laboratory values reflects the healthy baseline status of participants rather than a specific property of the extract.

The 62-participant sample was drawn from healthy adults, so the findings do not address safety in people with pre-existing hepatic, renal, or metabolic conditions, or those taking medications metabolized through the liver. Comparative claims about withanolide concentration and effective dosing relative to other commercial ashwagandha extracts originate with the manufacturer and were not independently verified as part of the published trial.

References

1. Benny IJ, Antony B, Benny M, Kuruvilla BT, Abraham G. Safety and tolerability assessment of Shoden, the Ashwagandha extract standardised with withanolide glycosides: An open label study in healthy volunteers. Adv Integr Med. 2026;13:100688. doi:10.1016/j.aimed.2026.100688

2. Arjuna Natural's Shoden Ashwagandha Extract Receives Peer-Reviewed Validation for Safety and Tolerability. Arjuna Natural Pvt. Ltd. September 1, 2026. Accessed September 2, 2026. Press release provided via email.

3. Tóth-Mészáros A, Garmaa G, Hegyi P, et al. The effect of adaptogenic plants on stress: a systematic review and meta-analysis. J Funct Foods. 2023;108:105695. doi:10.1016/j.jff.2023.105695

4. Natural Health Product Monograph: Ashwagandha (Withania somnifera). Natural and Non-prescription Health Products Directorate. Health Canada. February 28, 2025. Accessed September 2, 2026. https://webprod.hc-sc.gc.ca/nhpid-bdipsn/dbImages/mono_ashwagandha_english.pdf