Abstract
PRECLINICAL SAFETY AND TOXCITY STUDY OF WAMUPGEL IN WISTAR RATS

N. Danamurthy*, T. Srisai Mounika, Chandramounika and Aishwarya Utham

ABSTRACT

WAMUP is an aqueous based gel formulation containing 5% L-Arginine for topical application for both males & females. It is indicated for Female Sexual Arousal Disorder (FSAD), Dyspareunia and Lubrication of Dry Vagina and other menopausal disorders in females and mild to moderate erectile dysfunctions of males. The present study was performed to asses the systemic toxic effects of WAMUP GEL, when administered sub cutaneously to male and female Wistar Rats. All the animals were conditioned, randomized and divided in three groups (3 Females and 3 Males). Two groups of animals (TG-I and TG-II) were administered with 150mg/ml and 300mg/ml dose of L-Arginine respectively and another Group of 3 male and 3 female were kept as control (Group II-Control) and treated with vehicle solution. Animals were observed for a period 14 days after the administration. Parameters evaluated including clinical signs of toxicity, live phase of animals, cage side observations, and body weight and food consumption. Blood samples were collected on day 7 and 14 for hematology and clinical chemistry analysis. Animals were necropsied and vital organs were weighed and subjected to histopathological examination.[2,8] No mortality was observed in any group. There were no differences in body weight gains, live phase, physical activity and abnormal neurological observation between the control and test groups Rats throughout the study period. No major abnormal clinical signs were observed at the site of application. Their biochemical and hematological profiles were in normal range in all groups.[15] No significant differences were observed in the histopathology of various organs between control and test groups at different time points.[16]

Keywords: Clinical laboratory investigations, hematology, histopathology.


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