KSM-66 Ashwagandha Shows Favorable Safety, Tolerability at 2,000 mg/Day: Safety Study

A high-dose clinical study evaluating the safety of KSM-66 Ashwagandha root extract at a daily dose of 2,000 mg per day, found that the ingredient had a favorable safety and tolerability profile over a 12-week study period. The dose is more than three times the most commonly studied daily dose of 600 mg. The findings were published in Frontiers in Nutrition.

The prospective single-arm study enrolled 145 healthy adults between the ages of 18 and 65 who received the supplement daily for 12 weeks, making it the highest-dose safety evaluation of any standardized ashwagandha extract published to date.

Primary safety outcomes included lab monitoring of liver, kidney, and thyroid function at baseline, week 4, week 8, and week 12.

No meaningful changes were observed across the hepatic markers, including AST, ALT, alkaline phosphatase, and bilirubin. The same held for the renal markers, creatinine and blood urea nitrogen, and for the full thyroid panel, which included TSH, T3, and T4. No serious adverse events were reported throughout the study, while a few mild, transient adverse events occurred, resolving without medical intervention. No participants withdrew from the study due to safety concerns.

As a secondary outcome, the researchers evaluated participants with an SF-36 quality of life questionnaire; these findings, however, were exploratory, and shouldn’t be read as evidence of a treatment effect.

“KSM-66 Ashwagandha has an established safety record at the standard 600 mg/day dose across multiple rigorous clinical trials,” said Kartikeya Baldwa, CEO of Ixoreal Biomed, Inc., the manufacturer of KSM-66. “This study takes that evidence meaningfully further. Even at 2,000 mg/day over a 12-week period, KSM-66 was well-tolerated with no clinically significant changes observed in liver, kidney, or thyroid function in this group of healthy adults. For brands and formulators evaluating high-potency formats, these are encouraging safety data.”

This study comes after a prior safety study in which participants took a standard 600 mg dose daily for 12 months, marking the longest duration for a safety evaluation of any ashwagandha extract to date.