PHASE 2 NON-RANDOMISED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE NAGA SANGU PARPAM IN KABAYONI ROGAM ( VULVO VAGINAL CANDIDIASIS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome is assessed by reduction in clinical symptoms like pruritis of vulva vulvovaginal inflammation and curdy white discharge.
研究概览
简要总结
Vulvovaginal infections are one of the most frequently diagnosed conditions in women. Nearly all vulvovaginal infections are caused by the yeast Candida species, with over 80% of all infections is due to Candida albicans. In worldwide, vaginal candidiasis is the second most common type of vaginal infection. In India, the complaint of vaginal discharges very common, more than 80% of vaginal infections are caused by candida albicans.
The aim of the study is the management of “KABAYONIROGAM (VULVO-VAGINAL CANDIDISIS) with the Siddha Medicine NAGA SANGU PARPAMâ€
To study the safety profile and the efficacy of Siddha Medicine NAGA SANGU PARPAM in the treatment of KABAYONI ROGAM (Vulvovaginal candidiasis) . Primary outcome is assessed by reduction in clinical symptoms like pruritis of vulva, vulvovaginal inflammation and curdy white discharge. Outcome of the treatment is mainly assessed by Wet mount Examination and clinical prognosis.
As the literary evidences support the usage of drugs in the disease, a hypothesis is created in such a way that the efficacy of the NAGA SANGU PARPAM will be a better solution for KABAYONI ROGAM
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females of age between 18 to 45 yrs patients with whitish discharge Vulvovaginal itching erosions inflammation and erythematous surface is covered by whitish coat Positive candida albicans Diabetes mellitus.
排除标准
- •Sexually Transmitted diseases (Gonorrhoea,Syphilis,HIV) Non specific leucorrhoea Pregnancy and lactation Malignancy in uterus and Ovary Vulvovaginosis caused by other organism.
结局指标
主要结局
Primary outcome is assessed by reduction in clinical symptoms like pruritis of vulva vulvovaginal inflammation and curdy white discharge.
时间窗: One week
次要结局
- Secondary outcome is mainly assessed by comparing the safety parameters before and after the treatment(48 days)