Clinical Trial Reports No Liver or Kidney Injury with Standardised Ashwagandha Extract Over 24 Weeks
A 24-week, randomised, double-blind, placebo-controlled clinical trial found no statistically significant changes in liver or kidney function markers, nor related adverse events, in healthy adults consuming a standardised ashwagandha root extract. The findings contribute to the safety profile of the extract over the observed period.
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A clinical trial has indicated that a standardised ashwagandha root extract did not induce liver or kidney injury in healthy adults. The study provides further data supporting the safety profile of ashwagandha for potential long-term use in food supplements.
Participants were administered ashwagandha extract or a placebo. Throughout the study, researchers monitored key blood parameters associated with liver and kidney function.
### Monitoring Organ Function
To assess the impact on organ health, researchers measured serum creatinine and blood urea nitrogen (BUN) for kidney function. Liver function was evaluated through levels of serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), and alkaline phosphatase.
Results demonstrated no statistically significant changes in any of these markers in the ashwagandha group when compared to the placebo group. Furthermore, no adverse events directly related to liver or kidney function were observed in participants receiving the ashwagandha extract.
### Standardised Extract and Industry Context
The study used a standardised ashwagandha extract. The use of a standardised extract is considered important for reproducibility and for attributing observed effects directly to specific compounds.
Ashwagandha (*Withania somnifera*) is a widely used adaptogenic herb within the food supplement sector, frequently incorporated into products targeting stress management and cognitive support. While its applications are increasingly recognised, some medical literature has raised concerns about potential adverse effects, including liver injury. This clinical trial addresses these concerns by providing safety data, which is considered essential for fostering industry confidence and supporting regulatory acceptance.
The study's findings indicate no evidence of hepatotoxicity or nephrotoxicity associated with the tested ashwagandha extract. This contributes to the body of evidence supporting the safety of ashwagandha, particularly when using well-characterised, standardised extracts.