Krishna Musali Root Extract

About

What it is and where it shows up.

Krishna Musali (Curculigo orchioides Gaertn., Family: Amaryllidaceae) is an ancient Ayurvedic medicinal plant whose rhizomes/root extract are used in Rasayana (anti-aging), Vrushya (aphrodisiac), and Brimhana (nutritive) formulations. It is employed as a health supplement and nutraceutical ingredient primarily for its immunomodulatory, rejuvenating, and male reproductive health-supporting properties.

Safety summary

The regulatory and scientific consensus.

Animal acute toxicity studies found no mortality or abnormal behaviour up to 2000 mg/kg body weight, suggesting a high acute safety margin at typical supplement doses. However, a long-term rodent study showed that extremely high doses (120 g/kg over 180 days) may cause liver and kidney injury, indicating dose-dependent organ toxicity risk at suprapharmacological exposures. No formal ADI has been established by any major international regulatory body (FDA, EFSA, WHO), and human clinical safety data remain limited; the extract also exhibits estrogenic activity, which may pose risks in hormone-sensitive conditions.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permissible as a plant/botanical ingredient under FSSAI Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations, 2016 (Gazette notified 23.12.2016, enforcement from 01.01.2018). Specific health benefit claims require prior FSSAI approval. No individual monograph or maximum daily intake limit is explicitly defined for Krishna Musali in the FSSAI schedules; general botanical ingredient provisions apply.source
FDA (Food and Drug Administration) (United States)	Approved	Permissible as a botanical dietary supplement ingredient under DSHEA 1994 subject to FDA Good Manufacturing Practices (21 CFR Part 111). Not listed as GRAS for direct food use. No FDA GRAS notice or specific safety dossier found for Curculigo orchioides. Manufacturers bear responsibility for safety.source
EFSA (European Food Safety Authority) (European Union)	Under_review	No EFSA opinion or EU Novel Food authorisation found specifically for Curculigo orchioides (Krishna Musali) root extract. As a botanical not with a documented history of significant food use in the EU before May 1997, it would likely require Novel Food authorisation under Regulation (EU) 2015/2283 before commercial use. Status is effectively 'under_review' pending any application.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — The extract exhibits significant estrogenic activity in animal models (uterotrophic effects, vaginal cornification), and flavone glycosides from C. orchioides have shown oxytocic activity, making it potentially unsafe during pregnancy.

Lactation — No human safety data exist for use during breastfeeding; estrogenic phytoconstituents could theoretically affect lactation hormones or infant development via breast milk.

Infants — FSSAI nutraceutical regulations explicitly exclude products for infants up to 24 months; no safety data exist for this population, and estrogenic constituents pose developmental risk.

Children — No paediatric clinical safety data are available; estrogenic activity of rhizome extract may interfere with hormonal development in children.

Liver Disease — Long-term animal studies at very high doses showed liver injury; individuals with pre-existing hepatic conditions should avoid suprapharmacological intakes and use only under medical supervision.

Research citations

The sources behind this verdict.

1PubMed. Toxicity Assessment of Curculigo orchioides Leaf Extract Using Drosophila melanogaster: A Preliminary Study, 2022. pmc.ncbi.nlm.nih.gov
2FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, 2016. fssai.gov.in
3PubMed. Protective Effect of Curculigo orchioides Extract on Cyclophosphamide-Induced Neurotoxicity in Murine Model, 2014. pubmed.ncbi.nlm.nih.gov
4PubMed. Medicinal plants of genus Curculigo: traditional uses and a phytochemical and ethnopharmacological review, 2013. pubmed.ncbi.nlm.nih.gov
5PubMed. Evaluation of estrogenic activity of alcoholic extract of rhizomes of Curculigo orchioides, 2007. pubmed.ncbi.nlm.nih.gov

Independently researched5 citations