Affiliation:
1. Department of Rsashastra and Bhaishajya Kalpana, Institute of Teaching and Research in Ayurveda, Jamnagar, India
2. Department of Pharmacology, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India
Abstract
Abstract
BACKGROUND:
Tala Sindura is one such mercuro-arsenical formulation extensively used in Ayurvedic therapeutics without any noticeable side effects. Despite this, safety concerns have been raised on such Ayurveda formulations containing heavy metals such as mercury and arsenic as an integral component. So, there is a need to generate scientific evidences on safety aspects of such formulations to prove that they are safe and non-toxic.
METHODS:
In current study, safety profile of Tala Sindura has been evaluated through repeated dose 90-days oral toxicity study. Test drug was administered at TED (22.5 mg/kg), TED ×5 (112.5 mg/kg), TED ×10 (225 mg/kg), and RTED ×10 (225 mg/kg) orally once in a day for 90 days along with honey (vehicle) and distilled water in a dose of 5 mL/kg body weight. Safety of Tala Sindura was assessed on the basis of hematological, biochemical, and histopathological changes in Wistar albino rats.
RESULTS:
Tala Sindura did not produce any significant changes in hematological, biochemical and histopathological parameters at TED and TED ×5 dose levels. Mild cell infiltration with edematous changes were observed in kidney at TED ×10 dose level; however, these changes were reversed in recovery control.
CONCLUSION:
From the present study, it is concluded that Tala Sindura is safe for administration at therapeutic dose level when administered for 90 days in rats.