CTRI/2020/04/024457已完成不适用
A Study to Evaluate the Safety and Efficacy Of Female Intimate Wash Product in Maintaining a Healthy pH and Microflora in Healthy Indian Women.
ITC Life Sciences and Technology Centre1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年4月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety of Feminine Intimate Wash product
研究概览
简要总结
This is an Open label, safety and efficacy study.Women will be explained in detail about the study,those willing to participate,will be screened by a gynecologist. Women meeting the eligibility criteria will be enrolled in the study after completing the informed consent process.Day 0 assessments will be performed.Subjects will undergo assessment on week 04 for gynecological assessment,Dermatological assessment,Self assessment and Biochemical measurements for Ph,and Microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy women in the age group of 18- 55 years.
- •Atleast one instance of UTI in the past 6 months.
- •Women willing to abide by the study protocol and study restrictions including abstinence from: use of any other product besides the allotted product during the study course, changing their usual brand of sanitary products and laundry detergents during the study course,showering/ bathing / cleaning their genitals with the test product on the day of study visit,depilation of pubic hair through topical products/waxing/ shaving (Trimming with scissors allowed)during the study course,oral or topical Anti-biotic/ Anti mycotic/Anti inflammatory medicine or OTC / products without informing to the study investigator.
排除标准
- •Women who are pregnant or lactating
- •Women with a known history or present condition of allergic response to any cosmetic products/ fragranced product which may influence the study result.
- •Women with bacterial vaginosis/ candidiasis/ mycotic infections / active psoriasis/ eczema/ other active skin disorder / any form of chronic infection / allergy / disease which may influence the study result.
- •Women in the post menopausal age group
- •Women with vulvo-vaginal dryness
- •Women who are currently taking or had taken antibiotics course in the past 3 months
- •Women who have changed the contraceptive medications or Menopausal / Hormonal treatment in the past 3 months or are contemplating to do so.
结局指标
主要结局
Safety of Feminine Intimate Wash product
时间窗: Day 0, Day 28
次要结局
- Efficacy of the Feminine Intimate Wash product(Day 0, Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment PeriodAndrogenetic AlopeciaNCT05324293Hope Medicine (Nanjing) Co., Ltd16
撤回
1 期
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal TowelUrinary Tract InfectionsNCT02509403University of Alberta
已完成
不适用
A Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial CommunityNCT07036666Radicle Science500
已完成
3 期
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in AdultsAttention Deficit Disorder With HyperactivityNCT00246207Janssen-Ortho Inc., Canada32
进行中（未招募）
1 期
A Study of Multiple Doses of ISIS ISIS 396443 Delivered to Infants withGenetically Diagnosed and Presymptomatic Spinal Muscular AtrophySpinal Muscular Atrophy (SMA)MedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2014-002098-12-DEBiogen Idec Research Limited25