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Toxicological study of Balacaturbhadrika churna
Mukeshkumar B Nariya1, Parag Parmar, Vinay J Shukla
1Department of Pharmacology, Ayurveda Contraceptive Drug Research Institute (Central Council for Research in Ayurveda and Siddha), Ahmedabad, India.
Insights
Balacaturbhadrika churna, an Ayurvedic pediatric formulation, demonstrated excellent safety in acute and long-term oral toxicity studies in rats. Even at high doses, it showed no significant adverse effects, supporting its traditional use.
Area of Science:
- Ayurvedic Medicine
- Toxicology
- Pediatric Pharmacology
Background:
- Balacaturbhadrika churna is a traditional Ayurvedic formulation with a long history of use in pediatric care.
- Its prolonged safe use in children suggests a favorable toxicity profile.
Purpose of the Study:
- To evaluate the acute and long-term oral toxicity of Balacaturbhadrika churna in a rat model.
- To scientifically validate the safety of this Ayurvedic pediatric medicine.
Main Methods:
- Acute oral toxicity: single dose up to 2000 mg/kg in rats.
- Long-term toxicity: oral administration of 450 and 900 mg/kg for 45 consecutive days.
- Assessment of ponderal, hematological, biochemical, and histological parameters.
Main Results:
- No mortality or signs of toxicity observed up to 2000 mg/kg in acute toxicity testing.
- No significant adverse effects on studied parameters even at the higher dose of 900 mg/kg in long-term toxicity.
- The doses used were significantly higher than therapeutic levels.
Conclusions:
- Balacaturbhadrika churna exhibits a high safety margin in rats.
- The findings support the long-term safety of Balacaturbhadrika churna for pediatric use at therapeutic doses.
Abstract:
Balacaturbhadrika churna has an important place in pediatric practice in Ayurveda. Millennia of use of this formulation bears testimony to its safety when used for prolonged duration in children. This prompted us to initiate a long-term, acute oral toxicity evaluation of Balacaturbhadrika churna in rats. The study was carried out by administering Balacaturbhadrika churna orally once only in a dose up to 2000 mg/kg. For long-term toxicity, Balacaturbhadrika churna was administered in doses of 450 and 900 mg/kg orally for 45 consecutive days. The effects of the drug on ponderal changes, hematological, biochemical and histological parameters were noted. The acute toxicity experiment showed that the drug did not produce any signs and symptoms of toxicity (or mortality) up to the dose of 2000 mg/kg. Long-term toxicity results showed that, even at higher dose of 900 mg/kg, Balacaturbhadrika churna did not affect the parameters studied, to a significant extent. The doses employed for these toxicity studies were several times higher than normal clinical doses of Balacaturbhadrika churna, hence the observed changes will probably not become apparent at therapeutic dose level.
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