An Open Label Double Arm Randomised Controlled Clinical Study On Efficacy Of Guduchyadi Yonivarti In Upaplutha Yonivyapath Vulvovaginitis During Pregnancy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Significant reduction in signs and symptoms of Upapluta yonivyapath, vulvovaginitis during pregnancy based on grading
研究概览
简要总结
An open label double arm randomised controlled clinical study on efficacy of guduchyadi yonivarti in upapluta yonivyapath ,vulvovaginitis during pregnancy of age group 20 - 40 years for period of 7 days floowed by 1 week of follow up .During the study period 32 pregnant patients will be recruited and divided into two groups , Group A (Control drug ) and Group B ( Trial drug ) with 16 patients in each group .Group A will recieve Clingen and clotrimazole suppository and Group B will recieve Guduchyadi yonivarti for 7 days .Clinical assessment will be done for both subjective and objective criteria on 8 th day (o day ,8 th day and 15 day ) and statistical analysis will be done by considering the data of Day 0 (BT) and Day 15 (AT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Primi and multi gravida 2.Second and third trimester 3.Subjects with lakshanas of upapluta yonivyapad – yoni srava , yonikandu 4.Subjects with age group of 20 to 40 years.
排除标准
- •1.Subjects with age less than 20 years and more than 40 years 2.First trimester 3.Subjects suffering from systemic illness like Diabetes milletus , hypertension ,UTI 4.Subjects suffering from Sexually Transmitted Disease.
结局指标
主要结局
Significant reduction in signs and symptoms of Upapluta yonivyapath, vulvovaginitis during pregnancy based on grading
时间窗: Baseline, 15 days
次要结局
- Improved quality of life and prevent recurrence in patients diagnosed with Upapluta yonivyapath, vulvovaginitis during pregnancy based on grading(Baseline, 15 days)
研究者
Dr Ankitha M
Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,Bangalore