Acute and sub acute toxicity study and randomized clinical trial of polyherbal coded drug candicure in the management of acute vulvovaginal candidiasis

Abstract

Vulvo-Vaginal Candidiasis is common gynecological disorder. Clinical trials are designed to evaluate the effect of medical intervention with allopathic and herbal medicine to treat vulvo-vaginal candidiasis. The toxicity index and the safety profile of test drug were assessed on animals’ model. Toxicity study of polyherbal formulation was done in order to consider it safe before use. In acute toxicity study, a single dose of 2000 mg/kg was given to Swiss Albino mice and in sub-acute toxicity study three different doses were given to Wistar rats. Randomized Controlled Clinical Trials was conducted. Inclusion and exclusion criteria and informed consent from the patients were to be monitored. In acute toxicity study no morbidity and mortality noticed on single administration of dose 2000mg/kg/day. In sub -acute toxicity study no significant changes were observed in consumption of food and water, body weight, hematological parameters, Liver function test, renal function parameters and lipid profile. The statistical analysis showed C. albican was eradicated in 59 participants (78%) out of 75 participants by the use of Candicure (Test drug) and in 56 participants (74%) out of 75 participants by the use of Fluconazole therapy (Control drug). Chi-square test was applied and p-value was calculated 0.3101 which is greater than 0.05 showed that Candicure therapy and Fluconazole therapy is equally significant in eradication of C. albican. The acute and sub-acute toxicity study of polyherbal formulation on experimental animals is safe at a dose of 2000mg/kg/day. The clinical findings of randomized controlled trial revealed that the effect was almost comparable to control drug in eradicating the micro-organism.