New Clinical Data Supports Ashwagandha's Long-Term Safety Profile

Amidst increasing demand for adaptogenic ingredients, new clinical trial data supports the long-term safety and tolerability of ashwagandha (_Withania somnifera_) extracts. These studies offer insights for manufacturers, formulators, and brand owners regarding the ingredient's impact on vital organ function, particularly over extended periods. A clinical trial indicated that ashwagandha was well tolerated over a 24-week period, with no evidence of liver or kidney injury reported. This finding addresses a key area of consideration for long-term supplementation safety. ### Specific Extract Data Further studies corroborate these findings with specific ashwagandha extracts. A 12-week study demonstrated that KSM-66 Ashwagandha root extract was well tolerated at a dosage of 2,000 mg/day. Participants maintained normal liver, kidney, and thyroid parameters throughout the trial, providing extract-specific data. Similarly, a 90-day trial investigating Arjuna Natural's Shoden ashwagandha extract found no clinically significant changes in liver, kidney, or metabolic markers among 62 healthy adults. These results contribute to the body of evidence supporting the safety profile of standardised ashwagandha formulations. ### Broader Context of Research Beyond organ-specific safety, other recent trials have explored the broader effects of ashwagandha supplementation. A 90-day study on a sustained-release ashwagandha formulation reported it to be safe and to contribute to improvements in muscular strength, cardiorespiratory endurance, and general mental and physical wellbeing in active healthy adults. Another 60-day study noted ashwagandha's potential to contribute to improvements in stress, anxiety, and triglyceride levels in individuals experiencing mild stress, anxiety, and hypertension. These efficacy data, alongside the latest safety findings, may strengthen the ingredient's position in the health and wellness market. ### Regulatory and Industry Implications The accumulation of long-term safety data is relevant for regulatory compliance and fostering confidence within the industry. As the National Kidney Foundation advises caution with herbal supplements due to potential issues such as high potassium, evidence demonstrating the absence of adverse effects on organ function, including kidney and liver, is valuable. These studies provide foundational evidence for product development and may support marketing claims, contributing to ashwagandha products meeting safety standards for a global market.