Toxicological Study of a Siddha Sastric Formulation Arumuga Chendhuram in Rat Model.

The study was aimed to profile the acute and sub-acute oral toxicity of a herbo-metallic drug Arumuga Chendhuram (AC). AC was prepared classically and analyzed for elemental composition using X-ray Fluorescence. Acute oral toxicity study was done on female rats at AC 2 g/kg as single administration following OECD guideline 423. For sub acute toxicity study, AC was administered orally for 28 consecutive days suspended in vehicle (Honey + distilled water) to rats following OECD guideline 407. Four groups was allotted (10 rats/group), control received vehicle; the other received AC at 12, 24 & 48 mg/kg/day respectively. Mortality and abnormal clinical signs were observed. Haematological and biochemical parameters were analyzed using auto analyzer with standard kits and ANOVA-Dunnett test was performed for significant analyses. Gross necropsy and histopathology studies using H&E stain were done on major organs. Mercury and Lead were found more than the WHO permissible limits in XRF study. LD50 was found more than 2 g/kg. No-Observed-Adverse-Effect level of AC was seen at 24 mg/kg in 28 days of treatment. No abnormal findings were noted in high dose group organs. Administration of AC at its human therapeutic dose of 260 mg/kg in rat (24 mg/kg) is safe.

Vediuppu Chendhuram: Oxide form of salt petre and its in vivo toxicological profile.

Background: Vediuppu Chendhuram (VC) is a traditional Siddha mineral formulation applied to treat Urinary tract dysfunction such as burning micturation and retention of urine. It is synthesized through special oxidation of Vediuppu as narrated in the text Anubhoga Vaithiya Navaneetham. Physicochemical characterization of VC has been carried out using qualitative compound analysis and modern techniques such as Fourier transform infra-red spectroscopy, inductively coupled plasma analysis and scanning electron microscopy. Such study reveals the presence of heavy metals like arsenic, cadmium, mercury and lead are present below the detection limit and the presence of sodium, potassium, sulphur, phosphorus and calcium under acceptable limits. The primary objective of this work is to validate the safety of VC through animal model. Methods: The raw Vediuppu are procured from country drug store at Nagercoil, Tamilnadu and purified by the traditional procedure by soaking in Cow’s urine until it dried. The test drug VC is prepared by the process of Pudam (Oxidation) described in Anuboga Vaithiya Navaneetham 3rd part, pg no. 76-77. The safety profile is evaluated by doing acute oral toxicity and repeated oral toxicity studies under OECD guidelines on Albino wistar rats. Results: Animals were found to be safe upto 300mg/kg body weight in acute oral toxicity study. Repeated toxicity study of VC has revealed that upto 200mg/kg body weight; all the treated animals have survived throughout the dosing period of 28 days. But at the dose of 400mg/kg, exhibits mortality on 21st day of treatment. No significant changes in the body weight, food and water intake have been observed. Complete urine, haematology, biochemical analyses, gross necropsy and histopathological examination at the end of treatment did not reveal any abnormalities. Conclusion: Vediuppu Chendhuram is the safest drug under intended human adult dosages (520 mg – 1040 mg) as illustrated in the literature.