Safety and Efficacy of Formulation Containing Stem Cell Secretome and Liquorice Root Extract for Improving Vagina Laxity of Women in Malaysia: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product
研究概览
简要总结
This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome and licorice root extract in improving vagina laxity (VL) condition of women in Malaysia. This formulation may stimulate cell rejuvenation and trigger cell renewal efficiently as they contained rich mixture of natural, bioavailable polypeptides and plant extracts and these might help improving the VL condition in women. The study duration is 5 weeks and vagina assessment will be carried out at baseline, week 2 and week 5.The main objectives of this study are:
- To assess the vagina laxity of women in Malaysia after using the formulation.
- To observe any adverse effect occurrence with the use of the formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Malaysian women ( age 40 to 55 years old)
- •Complaint of vagina laxity
- •Willingness to participate in the study
排除标准
- •Pregnant and breastfeeding women
- •Doing any surgical or non-surgical procedures to improved vaginal laxity condition such as laser and radiofrequency before participating in the study that might affect the study outcome
- •Presence of illness or taking any medication that might impact the study outcome or participants well-being
研究组 & 干预措施
Formulation X
Participants will use the formulation once every 72 hour for 5 weeks
干预措施: Formulation X (Other)
结局指标
主要结局
Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product
时间窗: Baseline, Week 2 and Week 5
Vagina laxity questionnaire (VLQ) will be used to assess participant's vagina laxity conditions at baseline, week 2 and week 5. This is a self-reported tool where participants will be asking to score their vagina laxity on a scale of 1 to 7 (1= very loose, 2= moderately loose, 3= slightly loose, 4= neither tight nor loose, 5= very tight, 6= moderately tight, 7= very tight)
Adverse effect after using the formulation
时间窗: week 5
Based on adverse effect occurrence on participants that occur during study period (5 weeks)
Change in vagina tone from baseline and at week 2 and week 5 after using the product
时间窗: Baseline, Week 2 and Week 5
Vagina tone is measured using a perineometer (measurement of vaginal squeeze pressure). This assessment will be carried out by trained clinician at baseline, week 2 and week 5 and it will determine participant vagina tone.
次要结局
未报告次要终点