Oral toxicity evaluation of gokshuradi guggulu, an ayurvedic formulation

Abstract

Gokshuradi guggulu is an important classical polyherbal formulation used in Ayurvedic system of medicine for the treatment of various chronic diseases like kidney stones and diabetes. However, no scientific attempts were made to evaluate its oral toxicity. Hence, the present study evaluated the acute and 28 days repeated dose sub-acute oral toxicities of gokshuradi guggulu in rats. Gokshuradi guggulu was tested for its compliance using physicochemical and analytical parameters as per standards prescribed in Ayurvedic Pharmacopeia of India. In acute oral toxicity study, Wistar rats were orally administered a single dose of gokshuradi guggulu (2700 mg/kg) and clinical signs and mortality or moribund stage were observed for 14 days along with weekly body weight. On day 15, the rats were euthanized and the gross morphology was carried out during necropsy. In sub-acute (repeated dose) oral toxicity study, the rats were orally administered gokshuradi guggulu (270, 1350 and 2700 mg/kg) once daily up to 28 days. Clinical signs and mortality or moribund stage, weekly body weight, weekly feed and water consumptions, biochemical and hematological investigations, urine analysis, and major organ weights and histopathology were carried out. In acute and sub-acute toxicity studies, gokshuradi guggulu administration did not show any alteration in parameters or any adverse effect as compared to vehicle treated group. There was no mortality or moribund state observed in any group in both studies. Administration of gokshuradi guggulu in acute and 28 days repeated doses did not exhibit any toxicity or adverse effect at the doses used and NOAEL was found to be 2700 mg/kg.

Keywords:

• Ayurveda
• gokshura
• Tribulus terestris
• acute toxicity
• sub-acute toxicity

Acknowledgements

The authors are thankful to Mr. Shridhar Chougule, Regional Ayurveda Institute for Fundamental Research, Pune, Maharashtra, India for LC-MS analysis.

Disclosure statement

The authors declare no conflict of interest.

Additional information

Funding

The authors are thankful to the Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Govt of India, New Delhi for financial assistance to carry out these studies (Sanction Order No. 431/2014–15 vide letter F. No. 3–4/2014-CCRAS/Admin./IMR4/Pharmacology (4.2.4) dated 11 July 2014).