1. Clinical & Scientific Overview
Giloy / Guduchi (Tinospora cordifolia) (TIP-MED-000583, Reference Code [BOT-04]) is classified under
Medicinal Plants, Botanicals & Phytopharmaceuticals as a Pharmacognosy & Phytochemistry • Menispermaceae (Dried Mature Stem (Climbing stem with intact cork)).
Within the Indian regulatory and compendial framework, it is governed under Classical ASU Botanical (API Part I Vol I); must be microscopically and HPTLC-authenticated to exclude Tinospora crispa..
Standardised Pharmacopoeial Crude Drug / Extract (IP / API Reference)
Official Plant Part: Dried Mature Stem (Climbing stem with intact cork) | Marker Compounds: Diterpenoid furanolactones (Tinosporaside, Columbin), protoberberine alkaloids (Berberine, Palmatine, Jatrorrhizine), and arabinogalactan polysaccharides
Pharmacognosy, Phytochemistry & Botanical Standardisation
Accepted Botanical Binomial & Authority: Tinospora cordifolia (Willd.) Miers
Botanical Family: Menispermaceae
Official Authenticated Plant Part: Dried Mature Stem (Climbing stem with intact cork)
Major Phytochemical Constituents & IP/API Marker Compounds: Diterpenoid furanolactones (Tinosporaside, Columbin), protoberberine alkaloids (Berberine, Palmatine, Jatrorrhizine), and arabinogalactan polysaccharides
Traditional / Classical Ayurvedic Context: Classical Ayurvedic Jwarahara (febrifuge) and Rasayana (Sanshamani Vati / Guduchi Satva).
Modern Clinical Evidence Assessment (Clearly Distinguished from Traditional Use): Investigated for non-specific macrophage/immunomodulatory activity and supportive convalescence; lacks high-grade RCT evidence as a standalone antiviral cure.
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): Classical ASU Botanical (API Part I Vol I); must be microscopically and HPTLC-authenticated to exclude Tinospora crispa.
3. Mechanism of Action & Pharmacodynamics
Major Phytochemical Constituents & Pharmacological Actions: Diterpenoid furanolactones (Tinosporaside, Columbin), protoberberine alkaloids (Berberine, Palmatine, Jatrorrhizine), and arabinogalactan polysaccharides. Investigated for non-specific macrophage/immunomodulatory activity and supportive convalescence; lacks high-grade RCT evidence as a standalone antiviral cure.
4. Therapeutic Indications & Evidence-Supported Uses
- Traditional / Classical Context: Classical Ayurvedic Jwarahara (febrifuge) and Rasayana (Sanshamani Vati / Guduchi Satva).
- Modern Clinical Evidence Assessment: Investigated for non-specific macrophage/immunomodulatory activity and supportive convalescence; lacks high-grade RCT evidence as a standalone antiviral cure.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Pharmacognostic & Clinical Evidence Summary: Investigated for non-specific macrophage/immunomodulatory activity and supportive convalescence; lacks high-grade RCT evidence as a standalone antiviral cure.
Administration & Meal Timing: Authenticated Plant Part Used: Dried Mature Stem (Climbing stem with intact cork). CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
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 Tinospora cordifolia (Willd.) Miers or other members of the Menispermaceae family
- CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
Key Clinical Precautions: CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
8. Adverse Effects Profile
- CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
- CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
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.
- CRITICAL PHARMACOVIGILANCE & BOTANICAL AUTHENTICATION WARNING: Ministry of AYUSH and hepatology case series documented autoimmune-like drug-induced liver injury (DILI) linked to chronic unsupervised high-dose intake AND botanical adulteration with Tinospora crispa (which contains hepatotoxic clerodane furanoditerpenoids); avoid in autoimmune diseases (SLE, rheumatoid arthritis, autoimmune hepatitis) and monitor LFTs.
- 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.