Acute and Repeated Dose Toxicity Study of Clevira Syrup – A Polyherbal Formulation
Uma Narayanamurthy1
, Mirunalini.R2, Subha. V1, K. Manimekalai1, Sakthibalan K3 , Arther Paul. C4 Nagarajan K M4 and Sabarianandh JV1* 1Department of Pharmacology, MGMCRI, SBV University, Puducherry, Tamil Nadu, India.
2Department of Pharmacology, JIPMER, Puducherry, Tamil Nadu, India.
3Investigator, Ki3, CRO Puducherry, Tamil Nadu, India.
4Manager International Business, Apex Laboratories PVT.Ltd, Chennai. Tamil Nadu, India.
Corresponding author E-Mail :crony.8681@gmail.com
Abstract: Aim and Objectives: This study evaluated the acute and repeated dose toxicity effects of Clevira Syrup Polyherbal formulation (CSPHF), which was prepared from ten different herbs, well known and widely used in traditional medicine for the management of viral infections and other inflammatory disease conditions. Individually these herbs (Carica papaya, Melia azedarach, Andrographis paniculata, Vetiveria zizanioides, Trichosanthes dioica, Cyperus rotundus, Zingiber officinale, Piper nigrum, Mollugo Cerviana and Tinospora cordifolia )were completely safe, but the polyherbal formulation effects were not known. Thus, this study was done for the investigation of toxicological profile of CSPHF in Wistar Albino rats. Methods: As per OECD(Organisation for Economic Co-operation and Development) guidelines 423 and 407, Acute and Repeated dose toxicity study were proceeded. In the acute toxicity study a single dose of CSPHF (2000mg/kg) was administered orally to female Wistar rats and in repeated dose toxicity study, CSPHF was administered orally in Control group and three different doses (1000, 500 and 250mg/kg body weight) to both male and female wistar albino rats for 28 days. At the end of the study, the animals were euthanized, observed the external and internal morphology (Acute Toxicity) and assessed the effect of CSPHF on histopathological and biochemical parameters (Repeated Dose toxicity study). Results: In acute toxicity study, there were no visual signs of toxicity of CSPHF (2000mg/kg) observed, whereas in Repeated dose toxicity study Ischaemia, inflammation and hematoma of the internal organs were observed at 1000mg/kg dose, but no such toxic features were seen at 500 and 250mg/kg dose of CSPHF. Conclusion: The results of the Acute and Repeated Dose toxicity study could be authenticated in future studies, which will be more useful and evidence based for the management of Viral infectionsduring pandemics.
Keywords: Acute and Repeated Dose Toxicity; Clevira syrup; Polyherbal formulation Back to TOC