Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
研究概览
简要总结
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
详细描述
A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).
排除标准
- •Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.
- •Subjects also excluded were those with pregnancy,
- •Sexually inactive girls,
- •Age > 65 years, renal failure and steroid therapy.
- •Patients who did not give consent for pelvic examination,
- •Those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.
研究组 & 干预措施
1, Boric acid
600 mg vaginal pessaries for 14 days
干预措施: Boric (Drug)
2, Fluconazole
干预措施: Fluconazole (Drug)
结局指标
主要结局
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
时间窗: 15 days
次要结局
- Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion(15 days)