| Summary: | Background: Lauha Bhasma(LB) is a complex herbomineral preparation widely used as an Ayurvedic hematinic agent. It is an effective remedy for chronic fever (jīrṃa jvara), phthisis (kşaya), Breathlessness (śvāsa) etc., and possesses vitality enhancing (vājīkara), strength promoting and anti aging (rasāyana) properties.
Objectives: The present work was conducted to establish the safety aspects of the use of Lauha bhasma.
Setting and Design: LB was prepared by Ayurvedic procedures of purification (śodhana), sun drying (bhānupāka), sthālīpāka, followed by repeated calcination (māraṃa) and “nectarization” (amṃṛtīkaraṃa). The resultant product was subjected to acute and sub acute toxicity studies.
Materials and Methods: Acute and subacute toxicity study of LB was conducted in albino rats. Criteria for assessment included ponderal changes, change in biochemical parameters viz., LFT and KFT and hematological parameters. Histopathological studies of different organs including liver, kidney, spleen, testis etc., were also conducted to observe pathological changes if any.
Results: In the acute toxicity study, the animal group did not manifest any signs of toxicity and no mortality was observed up to 100 times the therapeutic dose (TD). Significant increase in blood urea (27.83%, P< 0.01), serum creatinine (30.92%, P< 0.05), Aspartate aminotransferase (15.09%, P< 0.05), and serum alkaline phosphatase (27.5%, P< 0.01) was evident in group IV (10 TD). A significant increase in serum total protein (6.04%, P< 0.05) level was observed in group III (5 TD). Histopathological examination of livers in group IV (10 TD) showed mild inflammation in terms of bile stasis, peri-portal hepatic inflammation and sinusoidal congestion; lymphocyte infiltration in kidney and intracellular deposits in the splenic tissue.
Conclusion: Lauha Bhasma was found to be safe at the therapeutic dose and also at five times the therapeutic dose levels. However, alteration in some of the biochemical and haematological parameters along with histopathological findings were evident at the highest dose level.
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