28-02-2013, 10:26 AM
Acute and Sub acute Toxicity Study of Ayurvedic Formulation (AYFs) Used for Migraine Treatment
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ABSTRACT:
Propose:
A combination of five classical ayurvedic formulations (Narikela Lavana, Sootashekhara Rasa, SitopaladChurna, Rason Vati and Godanti Mishran) has been employed as prophylactic remedy for migraine. These ayurvedicformulations (AYFs) contain certain Bhasma and plant materials. An investigation was initiated to evaluate safety profileof these AYFs in Sprague Dawley rats and Swiss Albino mice following OECD guidelines. Material and MethodAcute toxicity studies were done after ingestion of 5 g/kg of AYFs in a day in both the animal species. Sub acute toxicitystudies were carried in five different groups in which AYFs was administrated in various doses ranging from 1.47 –6.48g/kg for mice and 0.7 – 7.45 g/kg for rats. The highest dose were 10 times higher that the recommended human doseDetailed hematological, biochemical, necropsy and histopathological evaluation of organs was performed for all animalsResults: The AYFs was well tolerated and no toxic manifestations were seen in any animal. Mortality observed in highdose groups; 4% in rats and 6% in mice was not related to treatment.
INTRODUCTION
In the recent years complementary and alternative medicine (CAM) has upsurge globally for the treatment and prevention of many aliments which are non-communicable and chronic in nature 1. Most surveys agree that herbal remedies are amongst the most prevalent therapies and that headache/migraine is one of the most frequent reasons for trying plant-derived medications 2. CAM is often perceived by the public to be more helpful than conventional care for the treatment of headache 3. However, there is always apprehension about their safety, efficacy, toxicity and reproducibility of CAM therapies.
Ayurveda the traditional system of medicine of India was initially taught and practiced in a Guru-Shisya Parampara has now been institutionalized. Ayurveda is largely practiced in India under the patronage of Central and Provincial Government. An Ayurvedic Treatment Protocol (AYTP) developed by the principal author was tried for migraine treatment with encouraging results 4, 5 this AYTP consist of a herbo-mineral combination of five classical ayurvedic formulations (Narikela Lavana, Sootashekhara Rasa, Sitopaladi Churna, Rason Vati and Godanti Mishran) 6 along with regulated diet and lifestyle modification. The same AYTP was used by other ayurvedic physicians with similar results7
MATERIALS AND METHODS
Animals:
Six to eight weeks old male Sprague Dawley rats weighing 170 to 210 gms and female rats weighing 150 – 170 gms and Swiss Albino mice of either sex weighing between 18 - 22 gms were selected for the present study. The animals were kept in polypropylene cages with stainless lid with rice husk bedding. Individual animal was identified by specific marking and cages were identified with label pasted on cages with relevant information. Animals were housed at a temperature of 24 ± 2oC and relative humidity of 30 to 70 %. A 12:12 light: dark cycle was followed. All animals had free access to water and standard pelleted laboratory animal diet. The animals were acclimatized for 7 days before starting the experiment.
Acute Toxicity study:
Six female rats and mice were orally administered 5 g/kg suspension of the mixture of AYFs in three divided doses, at an interval of 30 minutes in a day. The equivalent human dose per day of these AYFs in rat and mice was calculated to be 0.7 g/kg and 1.47 g/kg respectively. The dose administered in rat and mice was approximately 7 times and 3.4 times higher than the normal human dose respectively. The animals were observed for first 4 hours of treatment to next 14 days. The evaluated parameters were mortality, signs and symptoms of toxicity, body weight, food consumption and necropsy observations.
RESULTS
Acute Toxicity study:
There were no signs of any toxicity in animals of both the species after the administration of the test dose of 5 g/kg suspension of the mixture of AYFs. All the animals showed similar food intake, body weight gain and clinical signs as that of the control group. No morbidity or mortality was observed in the treated animals. The necropsy studies did not detect any abnormality.
Sub Acute Toxicity study:
The animals from both the species showed normal body weight gain throughout the dosing period. No significant change in weight was noted in any of the groups. There was no difference in the food intake noted in rats. However, significant reduction in food consumption in mice was noted from second week of study in the medium dose, high dose and satellite treatment group in comparison to control group.