Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of patients with complete cure
研究概览
简要总结
Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Essential oils and other extracts of plants have evoked interest as sources of natural products. They have been shown to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of our knowledge, no study has examined the efficacy of cumin seed extract on relieving vulvovaginal candidiasis in vivo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women were 18-49 years old and were married;
- •They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study;
- •They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear;
- •Candidiasis culture was in agreement with clinical symptoms and patient's complaints.
排除标准
- •Pregnant and lactating women;
- •Those who had abnormal uterine bleeding;
- •Women with diabetes or autoimmune diseases;
- •Women refuse to participate in the study.
研究组 & 干预措施
Cumin seed extract
Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
干预措施: Cumin seed extract (Drug)
clotrimazole
Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.
干预措施: clotrimazole (Drug)
结局指标
主要结局
The percentage of patients with complete cure
时间窗: one week
cure is defines as absence of symptoms
次要结局
未报告次要终点