A Toxicity study on Ayaveera Chendhuram (அயவீர செந்தூரம்)

INTRODUCTION: Aya veera chendhuram (AVC) a metallic preparation have high privilege in curing chronic pain in various degenerative diseases. In my study to determine the safety profile of aya veeera chendhuram and for global acceptance of our Siddha metallic formulations, I choose AVC for my dissertation to ensure its safety as pre clinically. AIM AND OBJECTIVES: AIM OF THE STUDY: The aim of this study is to evaluate the toxicological profile of Aya Veera Chendhuram. OBJECTIVES : Based on the literature evidences, various sources of Ayam and Veeram have been collected and purified. At each stages of purification, compound analyses have to be done. After that, the purified Ayam and Veeram will be taken and used in the preparation of Aya Veera Chendhuram as per literature. Then, the finished product of Aya Veera Chendhuram is sent for elemental analysis to estimate the presence of any heavy metals and other organic and inorganic compounds. To analysis its safety, Aya Veera Chendhuram is subjected for acute and 28 days repeated oral toxicity evaluation under OECD guideline on rodents. Aya Veera chendhuram has been evaluated in the following aspects: 1. Collection of relevant literatures regarding Ayam and Veeram. 2. Analysis the compounds present in before and after purification of Ayam and Veeram. 3. Preparation of Aya Veera chendhuram as per textual method. 4. Physiochemical analysis of Aya Veera chendhuram. 5. Safety study of Aya Veera chendhuram on rodents. MATERIALS AND METHODS: TEST DRUG : AYAVEERA CHENDHURAM [AVC] Ingredients: Purified ayam (ferrum) – 1 palam(35 gm), Purified Veeram(Hydrargyrum per chloride) _ 1palam, Sunnambu theli neer( limestone water) _ sufficient quantity. Purification: Ayam: The purification of iron ore (Ayam) is carried out by soak it in fruit juice of syzygium cumini and kept in the sunlight to get dried. This process is repeated for six times. - Gunapadam thathu jeeva Vagupu, pg: 91. Veeram: Take Veeram and Piper nigrum seeds in the ratio of 1:3.Ground the seeds with rice pottridge until paste form. Gently cover the veeram with that paste and tie with a white cloth. Sufficient quantity of tender coconut water is add in to a mud pot. By the method of thulaiyandram, prepared veeram was tied witout dipping into the tender coconut water and heat for 11/2 hours (1/2 samam) - Sikicha rathina deepam, pg. no 37. Sunnambu thelineer: Mix the oyster shell with water in the ratio of 1:4, leave it for 4 hours until sedimentation. Finally gently take the upper zone of water without vigorous mixing. SUMMARY: Siddha system is the ancient traditional system followed in South India mainly in Tamilnadu. It incorporates many herbal, mineral and metal based medicines. veeram is mentioned under minerals and ayam is mentioned under metals. Ayaveera chenduram is one of the notable medicine in the treatment of arthritis, hemeplegia, ulcers and chronic pain associated with other degenerative disease. AVC was taken from the literature Anuboga Vaithya Navaneetham part I. The raw drug veeram and ayam was procured from country drug shop and authenticated at Siddha Central Research Institute. Raw drug was purified and the medicine was prepared as mentioned in the Siddha literature. Chemical analysis of unpurified and purified veeram sample indicates the presence of mercury, phosphate, iron and magnesium. Analysis of the AVC confirmed the presence of mercury, phosphate, iron, magnesium. In physico - chemical analysis of AVC the pH was found to be 8.3 - 8.5 and the loss on drying at 105ºC was 0.86% w/w. After HRSEM analysis, the particle size of the AVC was analyzed as 50-100nm In ICP-OES study, heavy metals like As, Pb, Cd were found below detection limit in unpurified and purified raw drugs. Mercury, calcium, iron, potassium, phosphorous, sodium levels were decreased in its level from unpurified to purified veeram. In ayam, calcium magnesium, silicon, phosphate and ferrous compound was seen drastically reduced after purification Mercury was detected in minimal level in the finally prepared medicine in AVC as (3.145). The toxicological evaluations were conducted as per OECD guidelines for safety evaluation of AVC. In Acute toxicity study there were no abnormal signs developed in wistar albino rats at fixed dose level within 24 hrs. At the end of the study no mortality and reduction in body weight of control and test group animals were observed. In Long term toxicity study there were no significant changes in behavioural signs, hematological parameters, biochemical investigation, body weight, food and water intake. The lymphocyte count was increased in test groups, but compared with control group it is not statistically significant. The histopathological study on the organs such as heart, lungs, kidney, and liver was normal in X and 5 X groups compared with control group. In 10 X group, the liver shows dilatation of sinusoids, degeneration of hepatocytes and necrosis, lungs shows congestion with emphysematous changes and other showed no abnormal histological variation. CONCLUSION: As the result of this study, it has been concluded that, The decrease in heavy metal content of the prepared medicine when compared to raw drug analyzed by sophisticated instrument reveals the potential background of Siddhars knowledge in the field of metals, minerals in medicine preparation. Mainly the mercurial content of the prepared medicine showed drastic reduction when compared to that of unpurified raw drug (124.514 to 3.145). No mortality was observed in preclinical studies, hence it is safe to humans and in future clinical studies have conducted to evaluate its efficacy