Acute Toxicity Study of Novel Ayurvedic Formulation Siddha Shalmali Kalpa (Classical Shalmali malabarica formulation) in Wistar Rat in vivo Experimental Study

Background

Traditional Ayurvedic Herbal remedies have long been used to improve and revitalize reproductive health. Siddha Shalmali Kalpa (Classical Shalmali malabarica formulation) is one such formulation that has long been praised for its aphrodisiac qualities. Its safety profile is still not well supported by scientific research, nevertheless.

Purpose

In order to lay the groundwork for next pharmacological and clinical studies, this study sought to assess the acute oral toxicity of Siddha Shalmali Kalpa in rats.

Materials and Methods

As per OECD Guideline 423, the study was carried out by giving a single oral dosage (2000 mg/kg body weight) of a formulation. Over the course of 14 days, the animals were monitored for physiological indicators, behavioural changes, clinical symptoms, and mortality. Weekly body weight measurements were made. Biochemical indicators of kidney and liver function were measured on day 15. The stomach, lungs, liver, and spleen were among the vital organs that underwent histopathological analysis.

Results

None of the treated animals showed signs of death or serious harmful consequences. Minor poisoning symptoms, like brief shaking and slight body tone changes, were noticed but went away on their own. Histopathological analyses of the organs revealed no anomalies, and biochemical markers stayed within normal ranges. Over the course of the trial, the body weight progressed normally.

Conclusion

At 2000 mg/kg, Siddha Shalmali Kalpa showed a good acute safety profile and was determined to be non-toxic. These results validate additional preclinical and clinical testing and provide credence to their safe use as possible herbal aphrodisiacs.