A Randomized, Double-blinded, Comparative Clinical Study to Evaluate the Efficacy and Safety of Feminine hygiene wash of Cavinkare
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- 3. self-assessment scoring by the subject
研究概览
简要总结
The subjects who fulfilled the inclusion criteria and exclusion criteria will be enrolled in the study. 54 Participants will be randomized (double -blinded) into groups.
Group 1- 27 Female Subjects- Feminine Wash of Cavinkare twice daily for two weeks.
Group 2- 27 Female Subjects- Vwash Plus Expert Intimate Hygiene of HUL twice daily for two weeks.
Dosing will done twice 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 .
-
Vulval swab will be taken before and end of the study.
-
In last visit, self assessment scoring by the subjects on subjects overall condition will be compared with pre treatment, improved , unchanged and deteriorated
4.Quality of life will be assessed using SF12 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
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
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
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 Anuradha MBBS MD
SRM Medical College Hospital and Research Centre