Abstract

PRELIMINARY ACUTE TOXICOLOGICAL SCREENING OF A NOVEL SIDDHA METALLO-MINERAL FORMULATION “KAALAMEGA NARAYANA CHENDHOORAM” AS MENTIONED IN “ATHMARAKSHA MIRTHAM ENNUM VAITHIYA SAARA SANGERAHAM” IN WISTAR ALBINO FEMALE RATS AS PER OECD GUIDELINES 423.

Dr. R. Abinaya*, Dr. R. Vijaya Nirmala, Dr. R. Karolin Daisy Rani and Dr. M. D. Saravana Devi

Abstract

Background: Kaalamega Narayana Chendhooram(KMNC) was a novel siddha formulation, had a indication for cancer as mentioned in the siddha classical literature Athmaraksha Mirtham Ennum Vaithiya Saara Sangeraham. Aim and Objective: The aim of the present study is to validate the the safety of a novel siddha metallo-mineral formulation Kaalamega Narayana Chendhooram as mentioned in Athmaraksha Mirtham Ennum Vaithiya Saara Sangeraham through a acute toxicological studies as per OECD guigelines 423. Methods: Administration of a natural medicines is used to cure the diseases of the human beings from the time immemorial. Every civilization had its own medicine and own tradition, they were considered as a traditional medicines. Siddha system of medicine was a one of the traditional system of medicine, which have been practiced by the south Dravidan people of the South India. This system of medicine contains flora, fauna, metals and minerals in their medicinal preparations. The current scientific committee of the World insisting that the administration of metals and minerals to human usage must be undergo the toxicity studies. Kaalamega Narayana Chendhooram(KMNC) was the one of the higher order medicine in Siddha formulation contains heavy metals in their formulation. As per the safety regulations drug should be proved its short and long term safety in rodents before extrapolating its clinical benefits in humans. Present investigation aimed at evaluating the safety profile of the test drug KMNC by acute oral toxicity in female wistar rats in accordance with OECD regulatory guidelines. In the acute study, a single dose of 2000 mg/kg was orally administered and animals were monitored for 14 days. Then the results of toxicity study was noted. In this paper an attempt was made to screen the acute toxicological studies of KMNC as per OECD 423 guidelines. Results: At the end of this preliminary acute toxicological research study, that the trail drug of a novel siddha metallo-mineral formulation Kaalamega Narayana Chendhooram as mentioned in Athmaraksha Mirtham Ennum Vaithiya Saara Sangeraham in acute toxicity study in Wistar rats showed that there were no significant toxicity changes seen during the 14 days of study. The body weight, food, water intake, behavioral, changes were slightly changes but they are within the non significant in compared with the control group. There was no mortality rate seen at 14 days of observation. Conclusion: The present preliminary acute toxicological research study of a potent siddha metallo-mineral formulation Kaalamega Narayana Chendhooram as mentioned in Athmaraksha Mirtham Ennum Vaithiya Saara Sangeraham showed some changes in the report because of its anticancerous effect, but the changes are non significant in compared with control no mortality rate was observed during the course of this study.

Keywords: Kaalamega Narayana Chendhooram, KMNC, Chendhooram, Siddha, metallo-mineral formulation, OECD guidelines, Acute toxicity 423.