A Comparative Clinical Trial on the Effectiveness of Brhatiphaladi Yoni Kalkadharana against Yoni Dhoopana in Vulvovaginal Candidiasis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of Candidal colony count by vaginal swab culture using Sabouraud’s media
研究概览
简要总结
Vulvovaginal candidiasis is the second most common vulvovaginal infection after Bacterial vaginosis caused by gram-positive yeast like fungus, Candida albicans. The disease is characterised by intense vulvar pruritus, thick curdy white cottage cheese like vaginal discharge, vaginal soreness, erythema, dysuria and dyspareunia.Symptomatically vulvovaginal candidiasis resembles with Slaishmiki yonivyapat in Ayurveda, which is characterised by pandu-pichila-seeta srava along with kandu and alpavedana or avedana. Brhatiphaladi yoni poorana and dhoopana is mentioned by Susruta Acharya in Uttaratantra Yonivyapat pradisheda adhyaya with an indication of yoni kandu and alpasparsa yoni are selected for the study.The study design is a non-randomised clinical trial, with a sample size of 18 per each group. Subjects aged 25 - 45 years, diagnosed with vulvovaginal candidiasis having thick curdy white vaginal discharge and vulvovaginal pruritis following the inclusion and exclusion criteria will be taken for the study. Data collection will be done by clinical observation through case proforma and relevant investigations will also be done. The medicine will be administered on the following basis. Participants are allocated to Group A and Group B. For trial group-A, Brhatiphaladi yoni kalkadharana for 7 days in the follicular phase will be given. Whereas for trial group-B, Brhatiphaladi yoni dhoopana for 7 days in the follicular phase will be given. Lodhradi gana kwatha will be given to both the trial group as the conventionally used internal medication. The assessment parameters include colony count in culture for Candida species, Likert scale and scoring pattern for assessing symptoms of Vulvovaginal candidiasis. Assessment will be done on the 0th, 8th and 31st day. All the necessary investigations required will be done in the study setting. Vaginal swab culture for Candidal colony counts using Sabouraud’s media will be done in the Microbiology laboratory. Results will be statistically analysed and summarised to arrive at conclusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Participants of age group 25- 45 years with Vulvovaginal candidiasis having complaints of thick curdy white vaginal discharge and vulvovaginal pruritis 2.Who are competent and willing to give written informed consent.
排除标准
- •1.Unmarried 2.Pregnancy 3.Uncontrolled Diabetes mellitus 4.Pelvic inflammatory disease 5.Infectious disorders of genital tract like HIV, Hepatitis B, Syphilis 6.Patients undergoing prolonged medication for various systemic illnesses 7.Dysfunctional uterine bleeding 8.Cervical lesions 9.Known case of malignancies.
结局指标
主要结局
Assessment of Candidal colony count by vaginal swab culture using Sabouraud’s media
时间窗: 1 week atter treatment and 4 weeks after study
次要结局
- 1.Assessment of thick curdy-white vaginal discharge using Likert scale & scoring pattern(2.Assessment of Vulvovaginal pruritis using Likert scale & scoring pattern)
研究者
Abhisha
Government Ayurveda College Tripunithura
