1. Clinical & Scientific Overview
Ashwagandha (Withania somnifera) (TIP-MED-000580, Reference Code [BOT-01]) is classified under
Medicinal Plants, Botanicals & Phytopharmaceuticals as a Pharmacognosy & Phytochemistry • Solanaceae (Dried Mature Tuberous Root (Never aerial leaves in classical IP monograph)).
Within the Indian regulatory and compendial framework, it is governed under Schedule E1 exempted; Classical ASU drug under Section 3(a) of Drugs & Cosmetics Act, 1940 (API Part I Vol I) and permitted botanical under FSSAI Nutraceutical Regulations (Root extract 250–600 mg/day; Ministry of AYUSH advisory prohibits substituting cheap leaf extract for root)..
Standardised Pharmacopoeial Crude Drug / Extract (IP / API Reference)
Official Plant Part: Dried Mature Tuberous Root (Never aerial leaves in classical IP monograph) | Marker Compounds: Withanolides (Withaferin A, Withanolide A, Withanolide D — IP/API marker >=0.3% to 2.5% total withanolides by HPLC) and sitoindosides VII–X
Pharmacognosy, Phytochemistry & Botanical Standardisation
Accepted Botanical Binomial & Authority: Withania somnifera (L.) Dunal
Botanical Family: Solanaceae
Official Authenticated Plant Part: Dried Mature Tuberous Root (Never aerial leaves in classical IP monograph)
Major Phytochemical Constituents & IP/API Marker Compounds: Withanolides (Withaferin A, Withanolide A, Withanolide D — IP/API marker >=0.3% to 2.5% total withanolides by HPLC) and sitoindosides VII–X
Traditional / Classical Ayurvedic Context: Ayurvedic Rasayana, Balya, and Medhya adaptogen used traditionally for convalescence, vitality, and sleep.
Modern Clinical Evidence Assessment (Clearly Distinguished from Traditional Use): Randomised clinical trials support cortisol reduction and perceived stress improvement (240–600 mg/day standardised root extract for 8 weeks); mild improvements in sleep latency. Evidence for disease modification in neurodegenerative or oncological conditions remains preclinical.
Quality Control, Adulteration & Contaminant Limits: Authenticate via HPTLC/HPLC marker assay; screen for heavy metals (Lead <=10 ppm, Arsenic <=3 ppm, Cadmium <=0.3 ppm, Mercury <=1 ppm), microbial load, and aflatoxins B1/B2/G1/G2 per IP/API.
Indian Regulatory Classification (ASU vs Phytopharmaceutical vs FSSAI): Schedule E1 exempted; Classical ASU drug under Section 3(a) of Drugs & Cosmetics Act, 1940 (API Part I Vol I) and permitted botanical under FSSAI Nutraceutical Regulations (Root extract 250–600 mg/day; Ministry of AYUSH advisory prohibits substituting cheap leaf extract for root).
3. Mechanism of Action & Pharmacodynamics
Major Phytochemical Constituents & Pharmacological Actions: Withanolides (Withaferin A, Withanolide A, Withanolide D — IP/API marker >=0.3% to 2.5% total withanolides by HPLC) and sitoindosides VII–X. Randomised clinical trials support cortisol reduction and perceived stress improvement (240–600 mg/day standardised root extract for 8 weeks); mild improvements in sleep latency. Evidence for disease modification in neurodegenerative or oncological conditions remains preclinical.
4. Therapeutic Indications & Evidence-Supported Uses
- Traditional / Classical Context: Ayurvedic Rasayana, Balya, and Medhya adaptogen used traditionally for convalescence, vitality, and sleep.
- Modern Clinical Evidence Assessment: Randomised clinical trials support cortisol reduction and perceived stress improvement (240–600 mg/day standardised root extract for 8 weeks); mild improvements in sleep latency. Evidence for disease modification in neurodegenerative or oncological conditions remains preclinical.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Pharmacognostic & Clinical Evidence Summary: Randomised clinical trials support cortisol reduction and perceived stress improvement (240–600 mg/day standardised root extract for 8 weeks); mild improvements in sleep latency. Evidence for disease modification in neurodegenerative or oncological conditions remains preclinical.
Administration & Meal Timing: Authenticated Plant Part Used: Dried Mature Tuberous Root (Never aerial leaves in classical IP monograph). Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Complex multicomponent phytoconstituent disposition involving intestinal deglycosylation by gut microbiota, hepatic Phase II glucuronidation/sulfation, and potential modulation of CYP450 and P-gp efflux pumps.
Intestinal microbial hydrolysis and hepatic Phase I/II biotransformation of secondary metabolites.
Avoid unstandardised herbal extracts in Stage 3–5 Chronic Kidney Disease (risk of hyperkalaemia or nephrotoxic adulterants).
Avoid high-dose concentrated botanical extracts in pre-existing hepatic disease; discontinue immediately if jaundice or transaminase elevation occurs.
7. Contraindications, Precautions & High-Risk Warnings
- Hypersensitivity to Withania somnifera (L.) Dunal or other members of the Solanaceae family
- Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
Key Clinical Precautions: Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
8. Adverse Effects Profile
- Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
- Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Verify botanical binomial authenticity (exclude adulterants/substitutes), HPTLC marker content, heavy metal limits (Pb, As, Cd, Hg), aflatoxins, and pesticide residues per IP/API standards.
Pharmacist Patient Counselling Points:
- Natural or herbal origin does NOT automatically mean risk-free; always disclose botanical supplements to your doctor and pharmacist.
- Rare idiosyncratic cholestatic/hepatocellular liver injury (warn patients to stop immediately if jaundice, dark urine, or pruritus occurs); increases serum T3/T4 (caution in hyperthyroidism); additive sedation with benzodiazepines/CNS depressants; avoid in pregnancy.
- Never discontinue prescribed allopathic chronic disease medicines (antihypertensives, antidiabetics, anticonvulsants, or antivirals) in favour of unverified herbal products.
Storage, Stability & Dispensing Safeguards: Store dried botanical material and extracts in airtight, light-resistant containers below 25°C protected from humidity and fungal/aflatoxin contamination.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacopoeia (IP — Herbs and Herbal Products Addendum); Ayurvedic Pharmacopoeia of India (API — Ministry of AYUSH); CDSCO Rule 122E Phytopharmaceutical Drug Guidelines.
Official Verification Portals: Ministry of AYUSH — Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) • Indian Pharmacopoeia Commission (IPC) — Herbal Monographs • CDSCO — Drugs and Cosmetics Rules (ASU & Phytopharmaceuticals)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.