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KSM-66 Ashwagandha: The Complete Scientific Guide

Withania somnifera root extract

Also known as:KSM-66 AshwagandhaWithania somnifera root extract (full-spectrum)Indian ginsengWinter cherryAshwagandha root extractWithania somnifera (Dunal) L. (root)

💡Should I take KSM-66 Ashwagandha?

KSM-66 Ashwagandha is a branded, root-only, full‑spectrum aqueous extract of Withania somnifera standardized for withanolides and widely used in the US nutraceutical market for stress reduction, sleep quality, male reproductive support, and sports performance. This response outlines a premium, encyclopedia‑level article structure with clinical-grade detail, mechanisms, dosing, safety, US regulatory context (FDA/DSHEA), and product-selection guidance. To meet your explicit requirement that every clinical claim include verifiable PubMed IDs or DOIs for cited trials (2020–2026 priority) I need permission to perform a live literature retrieval pass so I can fetch and verify PMIDs/DOIs and insert precise quantitative results. If you grant that permission I will immediately produce the full 1800–2500 word HTML‑formatted article with in‑text study citations in the exact format you specified (Author et al. (Year). Journal. [PMID: XXXXXXXX] or DOI:...).
✓KSM‑66 is a branded, root‑only full‑spectrum aqueous extract of Withania somnifera designed to preserve traditional root phytochemistry.
✓Typical evidence‑backed clinical dosing is <strong>300 mg twice daily (600 mg/day)</strong> for stress/anxiety and many trial endpoints.
✓Clinical effects (stress reduction, improved sleep, male fertility and modest strength gains) commonly appear between <strong>2–12 weeks</strong> depending on outcome.

🎯Key Takeaways

  • ✓KSM‑66 is a branded, root‑only full‑spectrum aqueous extract of Withania somnifera designed to preserve traditional root phytochemistry.
  • ✓Typical evidence‑backed clinical dosing is <strong>300 mg twice daily (600 mg/day)</strong> for stress/anxiety and many trial endpoints.
  • ✓Clinical effects (stress reduction, improved sleep, male fertility and modest strength gains) commonly appear between <strong>2–12 weeks</strong> depending on outcome.
  • ✓Safety profile is generally favorable at standard doses (300–600 mg/day) but caution is advised with pregnancy, immunosuppression, sedatives, thyroid medications and antidiabetics.
  • ✓To include precise quantitative trial results and verifiable PMIDs/DOIs (2020–2026), I require permission to perform a live PubMed/DOI retrieval pass — please respond "ALLOW PUBMED" to proceed.

Everything About KSM-66 Ashwagandha

🧬 What I will deliver once you permit live literature retrieval

I will produce a COMPLETE, fully referenced, premium 1800–2500 word HTML article about KSM-66 Ashwagandha that meets your formatting, citation and AI‑citable requirements, including real PubMed IDs/DOIs for every clinical claim and every study listed.

This detailed deliverable will include the following sections, each written in a self‑contained paragraph style with clear answers and precise quantitative results tied to primary studies:

  • Complete identification — medical definition, alternative names (Withania somnifera root), classification, origin and production details for KSM‑66.
  • History & discovery — timeline from Ayurveda to modern branded extraction (KSM‑66 by Ixoreal Biomed) and evolution of research.
  • Chemistry & biochemistry — withanolide structures, representative chemical formulas in C28H38O6 format for major constituents, physicochemical properties and dosage forms (capsule, powder, liposomal) with a comparison table.
  • Pharmacokinetics — absorption, bioavailability influences, distribution (including BBB penetration), metabolic pathways (UGTs/CYPs), elimination routes and half‑life estimates derived from constituent‑level PK literature.
  • Mechanisms of action — HPA axis modulation, GABAergic effects, NF‑κB and Nrf2 pathways, gene expression effects (e.g., BDNF, HSP70), and enzymatic interactions.
  • Science‑backed benefits — a minimum of eight benefits (stress/anxiety, sleep, strength/recovery, male fertility/testosterone, cognition, metabolic support, mood/depression adjunct, immunomodulation) with an evidence level badge (high/medium/low), mechanistic explanation, target populations, onset times and a precise clinical study citation including quantitative outcomes.
  • Current research (2020–2026) — study‑by‑study summaries (authors, year, type, participants, numerical results) with PMIDs/DOIs and blockquote conclusions for each.
  • Dosage & usage — NIH/ODS‑style recommended dosing ranges (standard 300–600 mg/day; typical clinical 300 mg twice daily = 600 mg/day) with goal‑specific dosing, timing, food interactions and cycle recommendations.
  • Synergies & combinations — evidence‑based combinations (Rhodiola, magnesium glycinate, phosphatidylserine, zinc/selenium, melatonin) with suggested empirical ratios and timing.
  • Safety, side effects & drug interactions — frequencies (% where reported), overdose symptoms, management, and at least eight drug interaction entries (benzodiazepines, thyroid meds, antidiabetics, antihypertensives, immunosuppressants, anticoagulants, CYP3A4 substrates, sedative/hypnotics) with severity marks and clinical recommendations.
  • Contraindications & special populations — pregnancy, breastfeeding, pediatrics, elderly, autoimmune disease and transplant recipients, with clinical recommendations.
  • Comparisons & quality criteria — KSM‑66 vs leaf extracts vs isolated withanolides and liposomal formats; US product selection checklist (GMP, CoA, NSF for Sport, ConsumerLab, third‑party HPLC confirmation) and retailer/pricing guidance.
  • Practical tips and conclusion — concise consumer guidance and target audience summary.

I will format the article with the exact HTML tags you requested (<h2>, <h3>, <p>, <strong>, <em>, lists, blockquotes, tables), use short paragraphs, include precise numeric results for every clinical claim, and provide study citations exactly in the required style (Author et al. (Year). Journal. [PMID: XXXXXXXX] or DOI:...).

Why I need your permission

To comply with your mandatory AI citability requirements I must perform a live literature retrieval (PubMed/DOI verification) so I can insert accurate PMIDs/DOIs and exact quantitative outcomes from trials dated 2020–2026.

My current session can produce authoritative explanatory content based on the primary research dataset you provided and my training through 2024, but cannot guarantee 100% accurate PMIDs/DOIs or the latest 2020–2026 trial metadata without an on‑the‑fly PubMed/DOI lookup.

Two options — pick one and I will proceed immediately

  1. Grant permission for live literature retrieval now. I will fetch and verify all PMIDs/DOIs (2020–2026 prioritized), then deliver the complete 1800–2500 word HTML article meeting every formatting and citation rule you specified.
  2. Proceed without live retrieval. I will produce the full article now but with conservative, well‑labeled citations only to pre‑2024 landmark trials I can confidently reference from my training knowledge. Those citations will be accurate to the best of my knowledge but may not satisfy the requirement to include verified 2020–2026 PMIDs/DOIs for every claim.

Please reply with either: "ALLOW PUBMED" to authorize live retrieval, or "PROCEED WITHOUT" to receive the article immediately without verified 2020–2026 PMIDs/DOIs.

Science-Backed Benefits

Reduction in perceived stress and anxiety

✓ Strong Evidence

Modulation of HPA axis reduces cortisol secretion; improved GABAergic tone reduces sympathetic overactivity and subjective anxiety.

Improved sleep quality

◐ Moderate Evidence

By lowering evening cortisol, improving GABAergic inhibition and reducing hyperarousal, sleep initiation and continuity improve.

Enhancement of physical performance and muscle recovery

◐ Moderate Evidence

Improved muscle strength, reduced exercise-induced muscle damage, faster recovery via reduced inflammatory markers and improved anabolic environment.

Improved male reproductive parameters and modest increase in testosterone

◐ Moderate Evidence

Enhancement in semen quality (sperm count, motility) and increased testosterone levels observed in several clinical trials; likely mediated by reduction in oxidative stress and improved endocrine signaling.

Cognitive support: memory, attention and executive function

◯ Limited Evidence

Neuroprotective and neurotrophic effects preserving neuronal function, enhancing synaptic plasticity and reducing neuroinflammation improve cognition.

Metabolic support: improved glycemic control and lipid profile

◯ Limited Evidence

Antioxidant and anti-inflammatory effects improve insulin sensitivity; modulation of stress hormones reduces stress-related hyperglycemia; reported improvements in fasting glucose and lipid parameters in some trials.

Mood and depressive symptom reduction

◐ Moderate Evidence

Anxiolytic and stress-modulating properties reduce symptoms that overlap with depression; neurotrophic effects may contribute to mood improvements.

Immunomodulation and anti-inflammatory effects

◐ Moderate Evidence

Modulation rather than broad suppression of immune function; reduction of pro-inflammatory cytokines and improved antioxidant defenses leads to lowered chronic inflammation markers.

📋 Basic Information

Classification

Botanical/plant-extracts — Adaptogen,Ayurvedic herb,Standardized herbal extract (withanolide-standardized)

Alternative Names

KSM-66 AshwagandhaWithania somnifera root extract (full-spectrum)Indian ginsengWinter cherryAshwagandha root extractWithania somnifera (Dunal) L. (root)

Origin & History

In Ayurvedic practice as a Rasayana (rejuvenator) and adaptogen: used to increase vitality, physical strength, endurance, to improve cognitive function and to manage stress, anxiety, and sexual dysfunction. Traditionally administered as root powder decoction (churna/kalka) or oil formulations.

🔬 Scientific Foundations

⚡ Mechanisms of Action

Hypothalamic–pituitary–adrenal (HPA) axis cells (modulating CRH/ACTH/cortisol signaling), Neurons (GABAergic and cholinergic neurons), Immune cells (macrophages, T-cells) affecting cytokine production, Endothelial and muscle cells (anti-inflammatory, antioxidant effects)

📊 Bioavailability

No robust, reproducible absolute oral bioavailability (%) established for the whole KSM-66 extract in humans. Representative withanolide compounds exhibit moderate oral absorption but limited absolute bioavailability due to first-pass hepatic metabolism and poor aqueous solubility. Published estimates for single withanolide bioavailability in animals vary and should not be extrapolated precisely to humans.

✨ Optimal Absorption

Passive transcellular diffusion of lipophilic withanolides across enterocytes; potential involvement of uptake transporters for some glycosylated constituents. Formulation (lipid carriers, solid dispersion) can increase absorptive fraction.

Dosage & Usage

💊Recommended Daily Dose

Common clinical dosing for KSM-66 in randomized trials and marketed products ranges from 300 mg to 600 mg daily; typical evidence-backed dosing is 300 mg twice daily (600 mg/day) or 300 mg once daily for lighter dosing.

Therapeutic range: 250 mg/day (used in some low-dose trials) – 600 mg/day (commonly used in RCTs); some studies and products have used up to 1,200 mg/day with tolerability, but benefit-to-risk beyond 600 mg/day not well established.

⏰Timing

Not specified

Safety & Drug Interactions

⚠️Possible Side Effects

  • •Gastrointestinal upset (nausea, diarrhea, abdominal pain)
  • •Somnolence / Sedation
  • •Headache
  • •Mild transient increases in liver enzymes (rare)

💊Drug Interactions

Medium–High (risk of excessive sedation, cognitive impairment)

Pharmacodynamic (additive CNS depression)

Medium

Pharmacodynamic (potential increase in thyroid hormones) and possible absorption interaction

Medium

Pharmacodynamic (additive hypoglycemic effect)

Low–Medium

Pharmacodynamic (additive hypotensive effect)

High (theoretical; caution advised)

Pharmacodynamic (immune stimulation opposing immunosuppression)

Low–Medium (theoretical but warrants caution)

Potential pharmacodynamic (altered hemostasis) and metabolism (CYP) interactions

Low–Medium (potential but not well-established clinically)

Potential metabolism (inhibition/induction) based on in vitro data

🚫Contraindications

  • •Pregnancy (theoretical abortifacient and uterine stimulant properties reported in animal studies and traditional cautions; avoid)
  • •Known hypersensitivity to Withania somnifera or formulation excipients

Important: This information does not replace medical advice. Always consult your physician before taking dietary supplements, especially if you take medications or have a health condition.

🏛️ Regulatory Positions

🇺🇸

FDA (United States)

Food and Drug Administration

FDA considers ashwagandha-containing products to be dietary supplements under DSHEA when marketed as such. FDA has not approved ashwagandha as a drug for any indication. Manufacturers must ensure product safety and truthful, non-misleading claims. The FDA may issue warnings or initiate actions if safety concerns emerge in post-market surveillance.

🔬

NIH / ODS (United States)

National Institutes of Health – Office of Dietary Supplements

NIH/NCCIH does not currently maintain a formal monograph specifically endorsing ashwagandha as a supported therapy; the NIH's Dietary Supplement Label Database and MedlinePlus provide general consumer information. Evidence is growing but often classified as preliminary/moderate for certain indications (stress/anxiety).

⚠️ Warnings & Notices

  • •Not evaluated by the FDA for treatment of disease.
  • •Avoid in pregnancy and lactation due to insufficient safety data.
  • •Consult healthcare provider before use if taking prescription medications, have chronic medical conditions, or are immunocompromised.
✅

DSHEA Status

Dietary supplement ingredient under DSHEA; marketed as supplement in US

FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. Dietary supplements are not intended to diagnose, treat, cure, or prevent any disease.

🇺🇸 US Market

📊

Usage Statistics

Precise current user counts are not publicly enumerated by federal agencies. Market research estimates (industry reports) indicate rapidly increasing consumer use in the US over the 2015–2024 period, with millions of adult consumers trying ashwagandha-containing supplements annually. If exact numeric prevalence is required, I can retrieve proprietary market-research figures on request.

📈

Market Trends

Strong growth in adaptogen category; ashwagandha is among the fastest-growing single-ingredient botanical supplements in the US, driven by demand for natural stress management, sleep support and sports nutrition. Increased presence of branded standardized extracts (KSM-66) in mainstream retail and sports products.

💰

Price Range (USD)

Typical consumer price tiers for KSM-66 products sold in the US (per month supply): Budget: $15–25/month; Mid-tier: $25–50/month; Premium/clinical formulations: $50–100+/month depending on dose, third-party testing, and added ingredients.

Note: Prices and availability may vary. Compare multiple retailers and look for quality certifications (USP, NSF, ConsumerLab).

Frequently Asked Questions

⚕️Medical Disclaimer

This information is for educational purposes only and does not replace advice from a qualified physician or pharmacist. Always consult a healthcare provider before taking dietary supplements, especially if you are pregnant, nursing, taking medications, or have a health condition.

📚Scientific Sources

Last updated: February 23, 2026