Repeated dose oral toxicity of Trivanga Bhasma in Swiss albino mice

Abstract

Trivanga Bhasma, a metallic preparation containing Bhasmas of Naga (lead), Vanga (tin) and Yashada (zinc), was studied for repeated dose toxicity in Swiss albino mice to estimate No Observed Effect Level (NOEL) or No Observed Adverse Effect Level (NOAEL). A total of 80 Swiss albino mice of either sex with an average body weight of 28-30 g were equally divided into four groups (Group I, II, III, and IV). Group I served as control and was given vehicle (honey: water in 2:3 ratio) Group II, III, and IV received Trivanga Bhasma @ 7.8, 39.5,and 78 mg/kg body weight for 90 consecutive days. The effect of drug was assessed on body weight, feed and water consumption changes, hematological, and histopathological parameters. At the end of the study, all animals were sacrificed and examined for gross pathological changes. Histopathological evaluation was performed for control and high dose group. Trivanga Bhasma was found to be safe. No significant clinical signs were noted in all groups studied. No major alterations were observed during histopathological evaluation. Hence, dose rate of 78 mg/kg body weight was established as NOAEL. It is suggested to carry out a toxicity study at possible higher doses and in a different species so as to establish target organ of toxicity.

Chemical Compositions of Metals in Bhasmas and Tibetan Zuotai Are a Major Determinant of Their Therapeutic Effects and Toxicity

“…Shodhita Tamra is safer than Ashodhita Tamra , indicating the importance of Shodhana in Bhasma preparation [ 38 ]. In another study, mice were given orally Trivanga Bhasma (Pb, Sn and Zn) at 1, 5, and 10 TED dose daily for 90 days, and no overt abnormal changes in the body weight, feed and water consumption, hematology, and histopathological parameters were observed [ 96 ]. In mice chronically dosed with the Tibetan medicine Zuotai for 135 days at the clinical dose, no abnormality in behavior and overt histopathology occurred.…”

Common Ayurvedic, Chinese traditional and Unani antidiabetic formulations- a review

“…Trivanga bhasma (TB) is a metallic preparation containing bhasmas of Naga , Vanga , and Yashada , i.e., lead, tin, and zinc, respectively ( Jamadagni et al, 2017 ). Sprague Dawley rats were injected with streptozotocin (STZ) to induce diabetes followed by dosing of drugs (TB with herbal ingredients (bhawna) and without herbal ingredients) in a human equivalent therapeutic dose i.e., 200 mg/kg for 30 days.…”

Prospective Application of Nanoparticles Green Synthesized Using Medicinal Plant Extracts as Novel Nanomedicines

“… 62 Similarly, toxicity study of Naga Bhasma and Trivanga Bhasma which contains Lead also showed no toxicity in rats for up to the treatment concentration 60 and 78 mg/kg, respectively. 23 , 24 However, administration of higher than therapeutic dose of Tamra Bhasma for 28 days to rats showed mild toxicity in kidney, liver, thymus and heart. 49 On the other hand, few case reports claim that Bhasma has toxic effects due to higher concentration of metals.…”

“… 22 , 23 The biocompatibility of Bhasma has been demonstrated in recent studies. 24 , 25 The metals showed toxic effects when present in macro size and showed medicinally beneficial effects when present in micro or nano size. 26 The need for repeated washing, drying and puta steps makes the process of Bhasma preparation time consuming.…”