Efficacy of probiotics in treating dermatophytosis

Dr Pratik Gahalaut1 个研究点分布在 1 个国家目标入组 35 人开始时间: 2023年5月15日最近更新: 2023年10月6日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 35
试验地点: 1
主要终点: 1. Biochemical (in serum)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

As per WHO dermatophytosis affects 25% of world population. There are only few anti-fungals available for treating the dermatophytosis, mainly belonging to only 2 anti-fungal families. This increases changes of cross-resistance. Further side effects of these drugs hamper effective treatment of mycoses. Probiotics are normal resident flora of gut, which can be formulated as different products. Lactic acid bacilli are commonly used as probiotics which have shown antifungal activities in vitro agaiinst dermatophytes. Hence this RCT is planned to evaluate the effect of administering probiotics as an adjuvant treatment in patients of dermatophytosis . Null hypothesis is : There will be no effect of probiotics on the various biochemical parameters in serum compared to a placebo.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 59.00 Year(s)（—）
性别: All

入选标准

•Patients above the age of 18 to 59 years with clinical evidence of Dermatophytosis & who are willing to take part in study with written informed consent.

排除标准

•Pregnant or lactating women
•Severe cardiac, pulmonary, gastrointestinal, renal, hepatic, or neurological disease and uncontrolled diabetes mellitus or neoplasia
•Known hypersensitivity to oral or topical antifungal agents, 4.Treatment with systemic antifungal agents in the previous one month, systemic antibiotics in the previous 2 weeks, corticosteroids or immunosuppressant in the past 6 weeks, or any investigational drug in the previous 3 months.
•Patients with concomitant any other skin disease.
•Patients who are not KOH positive at the baseline.