About
Dashamoola ('ten roots') is a classical Ayurvedic polyherbal formulation composed of the dried roots of ten medicinal plants grouped as Brihatpanchamula (Bilva, Agnimantha, Shyonaka, Patala, Gambhari) and Laghupanchamula (Shalaparni, Prishniparni, Brihati, Kantakari, Gokshura). It is widely used in traditional Indian medicine as an anti-inflammatory, analgesic, immunomodulatory, and febrifugal agent, typically consumed as a decoction (kwath), fermented preparation (arishta), or medicated oil.
Safety summary
Dashamoola has a long history of traditional use and preclinical studies support analgesic and anti-inflammatory activity; however, large-scale, phase-controlled clinical safety trials are lacking. Quality-control concerns exist regarding adulteration, botanical identity disputes, and contamination with heavy metals (arsenic, lead, mercury, cadmium, chromium, nickel) and organochlorine pesticide residues detected in commercial raw drug samples. No established ADI exists; no IARC classification has been assigned; EFSA and FDA have not evaluated it as a food ingredient.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | No EU-wide approved use as a food additive or novel food. May fall under botanical food supplement provisions subject to member-state national regulations; EFSA has not issued a formal opinion specific to Dashamoola. Marketing as a food supplement is possible in some member states under national law.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Not recognised as GRAS for use as a conventional food additive. May be marketed as a botanical dietary supplement under DSHEA 1994 without pre-market approval, but no health claims are permitted without substantiation. FDA has not issued a specific monograph for Dashamoola.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Recognised as a plant/botanical ingredient permissible in Health Supplements and Nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. As a classical Ayurvedic formulation it is also regulated under the Drugs and Cosmetics Act 1940 by Ministry of AYUSH. No specific maximum daily intake has been established under FSS regulations; therapeutic doses follow Ayurvedic Formulary of India (AFI) guidelines.source |
Who should approach with care
Research citations
- 1PubMed. Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care in the rehabilitation of stroke – a clinical trial protocol, 2024. 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. Experimental evaluation of analgesic, anti-inflammatory and anti-platelet potential of Dashamoola, 2015. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Botanical identity of plant sources of Daśamūla drugs through an analysis of published literature, 2013. pmc.ncbi.nlm.nih.gov
- 5PubMed. Toxic metals and organochlorine pesticides residue in single herbal drugs used in important ayurvedic formulation - 'Dashmoola', 2006. pubmed.ncbi.nlm.nih.gov