Ashwagandha Safety: What a Recent Study Says
Quick Summary: A recent study found that taking a specific Ashwagandha root extract (KSM-66) at 600mg daily for 8 weeks was safe for healthy adults. The study looked for side effects and found no serious problems.
Is Ashwagandha Safe?
This study aimed to find out if Ashwagandha is safe to take. Researchers gave some healthy adults Ashwagandha and others a placebo (a "dummy" pill). They checked for any negative effects on the body. The good news? The study found no serious safety concerns with the tested Ashwagandha extract.
Study Details
- Who was studied: 52 healthy adults from India, aged 18-50.
- How long: 8 weeks.
- What they took: 300mg of KSM-66 Ashwagandha root extract twice a day (total of 600mg daily) or a placebo.
What This Means For You
This study suggests that taking 600mg of KSM-66 Ashwagandha daily for a short time is likely safe for healthy adults. It didn't find any significant problems with liver or kidney function, and no serious side effects were reported.
Study Limitations
It's important to remember:
- The study was small, so rare side effects might have been missed.
- It only lasted 8 weeks, so we don't know about long-term safety.
- The study only included healthy adults from one region.
- The study did not test for any health benefits, only safety.
Technical Analysis Details
Key Findings
This study concluded that Withania somnifera (Ashwagandha) root extract (KSM-66®) at 600 mg/day was safe and well-tolerated in healthy adults over 8 weeks. No serious adverse events (SAEs) occurred. All safety parameters—including liver enzymes (ALT, AST), kidney function (creatinine, BUN), hematology, and vital signs—remained within normal ranges with no statistically significant differences between Ashwagandha and placebo groups (p>0.05). Mild adverse events (e.g., headache, GI discomfort) were equally reported in both groups (5.8% Ashwagandha vs. 7.7% placebo).
Study Design
Double-blind, randomized, placebo-controlled trial. 52 healthy Indian volunteers (aged 18–50 years; 58% male) were randomized to Ashwagandha (n=26) or placebo (n=26). Exclusion criteria included chronic illnesses, pregnancy, and Ashwagandha use within 3 months. Primary endpoints were safety/tolerability via clinical labs, physical exams, and adverse event monitoring over 8 weeks.
Dosage & Administration
Standardized Ashwagandha root extract (KSM-66®; 5% withanolides) at 300 mg twice daily (total 600 mg/day), administered orally in identical capsules. Placebo matched in appearance/taste. Compliance was confirmed via capsule count (>95% adherence).
Results & Efficacy
No efficacy outcomes were measured, as this was a safety-focused trial. Safety results showed:
- Liver/kidney markers: ALT, AST, creatinine, and BUN changes were non-significant (p>0.05; 95% CIs overlapping zero).
- Hematology: No clinically relevant shifts in RBC, WBC, or platelet counts.
- Adverse events: 3 mild events in Ashwagandha group (headache n=1, GI upset n=2) vs. 4 in placebo (headache n=2, dizziness n=1, fatigue n=1); no group difference (p=0.68).
Limitations
Small sample size (n=52) limits statistical power for rare adverse events. Short duration (8 weeks) precludes long-term safety conclusions. Homogeneous cohort (Indian adults only) reduces generalizability to other ethnicities or clinical populations. Exclusion of individuals with comorbidities means safety in diseased states remains unverified. No assessment of drug-herb interactions.
Clinical Relevance
For supplement users, this study supports the short-term safety of KSM-66® Ashwagandha root extract at 600 mg/day in healthy adults. Users can reasonably expect minimal risk of organ toxicity or severe side effects within this dose/duration. However, it does not validate efficacy claims (e.g., stress reduction), as the trial design excluded efficacy endpoints. Long-term users should consult healthcare providers, as safety beyond 8 weeks is unstudied here. Manufacturers should note that results apply specifically to KSM-66®—not all Ashwagandha extracts.
Original Study Reference
Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.
Source: PubMed-Human
Published: 2021-03-01
📄 Read Full Study (PMID: 33338583)
