Evaluation of Polyherbal Coded Drug Candicure in the management of Acute vulvo-vaginal Candidiasis

Abstract

Background Current studies on the prevalence of vaginal candidiasis infections approximately half of the women population of the world has been suffering from this disease. It is most common gynecological disorder. This disease causes discomfort, pelvic pain, painful sexual act, healthcare cost and involve in considerable morbidity. It is not life threatening disease. Different antifungal agents available such as imidazole, triazole, clotrimazole, Fluconazole for its treatment. The antifungal agent available but they are limited in number, have adverse effects, resistance of candida to these agents and relapse of the candida infections. In order to overcome the problem of less availability of drugs needed to treat candidiasis, with traditional medicine derived from medicinal plants. This encouraged the search for new and dynamic anti-C. albicans agents from plant sources. Aims and Objectives Clinical trials are designed to understand the nature of disease, its associated symptoms, and patient’s response towards management. The study has aim to evaluate the effect of medical intervention with allopathic and herbal medicine to treat vulvo-vaginal candidiasis. The main objectives of the study are; to determine the efficacy of test drug Candicure to cure the Vulvo- Vaginal candidiasis, to compare the effectiveness of Polyherbal formulation Candicure vs. Standard allopathic. Antifungal (fluconazole 150 mg) in treatment of vaginal candidiasis, to assess the safety of trial drug. The toxicity index and the safety profile of test drug is assessed. Toxicity study of polyherbal formulation is important in order to consider them safe before use. The toxicity study of test drug is conducted on animals’ model. iv The purpose of the toxicity study is to establish the therapeutic index, i.e. the ratio LD50: ED50. The narrow the margin, the more likely the drug produce adverse effects, the higher the index the safer the compound. Acute toxicity study is usually conducted to assess the lethality and lethal dose. The test drug is prepared by the combination of plants having antifungal activity. The study has been conducted to measure the antifungal activity of polyherbal formulation containing different herbs. Methodology Clinical Trials Study Design Randomized Controlled Clinical Trials Setting and Duration This study were conduct in Shifa ul Mulk Hospital Hamdard University Karachi and Naseem ul Sehat Eastern Medicine Clinic (PHC: Reg-No-13349). Eligibility In clinical trials, ages eligible for the study were fixed between 18-57 years. Only married females were eligible for study: inclusion and exclusion criteria and informed consent from the patients were to be monitored. Subject Selection Trial were be conducted on approximately 150 patients from both groups (75 patient from control and 75 from test group) between ages of 17-50 years irrespective of socioeconomic status. v Intervention After the diagnosis of participants, they were randomly classified into two groups of 75 each. Participants in Group 1(control group) will prescribe capsule fluconazole 150mg stat (single dose) and those in Group 2 (Test group) were prescribe Candicure 500mg capsule thrice daily for seven days. Short term effectiveness assesses by eradication of organism on follow up visit after one week and long term follow up was assess by negative high vaginal after 2 weeks of the 2nd visit. Toxicity Study In the acute toxicity study, a single dose of 2000 mg/kg was given to Swiss Albino mice. The mice were observed for 72 hours for changes in behavioral and physical symptoms changes. In sub-acute toxicity study three doses of polyherbal formulation (50 mg/kg/day, 100 mg/kg/day and 200 mg/kg/day) were administered for a period of 28 days. Blood sampling was done on animals on 28 days for analysis of biochemical and hematological parameters. The animals were then sacrificed, liver and kidney obtained and histopathological analysis was done.