A Randomized Double blinded Comparative Pilot Clinical Study to Assess the Efficacy and Safety of Feminine Hygiene Wash of Cavinkare
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. An assessment for vulval pH and degree of pruritus,burning, vulvo vaginal erythema and oedema, dryness and dyspareunia
研究概览
简要总结
- The subjects who fulfilled the inclusion criteria and exclusion criteria will be enrolled in the study
- 24 participants will be randomized (double-blinded) into groups
- Group 1- female subjects use feminine hygiene wash of cavincare for feminine hygiene twice for daily 2 weeks
- Group 2 - female subjects use - VWash Plus expert intimate hygiene of HUL for feminine hygiene twice for daily 2 weeks
Dosing will done twicw daily as topical wash for 2 weeks in the morning and evening
Subjects will be asked to visit the facility on week 1 and week 2
Primary outcomes
- An assessment will be made for vulval pH degree of purities, burning, vulvo vaginal erythema and oedema, dryness and dyspareunia before and after the study 2. Vulval swab will be taken before and end of the study 3. In last visit, self assessment scoring by the subjects on subjects overal condition will be compared with pre treatment, improved, unchanged and deteriorated. 4. based on above three primary outcomes, the efficacy of treatment will be assessed by the investigator. 5. Quality of life will be assessed using Sf 12 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Proper written informed consent obtained from the patient before any procedure performed.
- •Healthy females with perineal discomfort between the age group of 18-65 years.
- •Subjects not have participated in any other clinical trial during the past 3 months.
排除标准
- •Female Subjects with sexually transmittable diseases and immune-compromised state & menstrual irregularities.
- •Pregnant or lactating women
- •Subjects with known history of vaginal candidal infections.
- •Hypersensitivity to any of the components of the test or reference formulation.
- •The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
1. An assessment for vulval pH and degree of pruritus,burning, vulvo vaginal erythema and oedema, dryness and dyspareunia
时间窗: Baseline and at 2 weeks
2. Vulval swabs will be taken before administering the
时间窗: Baseline and at 2 weeks
test product for bacterial and fungal culture. Swabs will
时间窗: Baseline and at 2 weeks
also be taken at the end of the study
时间窗: Baseline and at 2 weeks
3. self-assessment scoring by the subject
时间窗: Baseline and at 2 weeks
on subject’s overall condition
时间窗: Baseline and at 2 weeks
4. Quality of life will also be assessed using SF 12
时间窗: Baseline and at 2 weeks
questionnaire
时间窗: Baseline and at 2 weeks
次要结局
- To monitor for any adverse events during the study period(Baseline to 2 weeks)
研究者
Dr Uthpala Vadakaluru
Mahatma Gandhi Medical College and Research Institute