A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vaginal Health and Balance
研究概览
简要总结
This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at birth
- •Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
- •Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
- •Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
- •Has used a boric acid suppository before
- •Willing to avoid the use of any intra-vaginal products during the study product use
- •Willing and able to follow the study protocol
排除标准
- •Surgeries or invasive treatments in the last six months or planned during the study period
- •Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
- •Known allergies to the product ingredients
- •Diagnosed with chronic health conditions impacting participation
- •Pregnant, breastfeeding, or trying to conceive
- •History of substance abuse
- •Current or former smoker within the past six months
- •Unwilling to follow the study protocol
- •Currently participating in any other clinical trial or perception study
研究组 & 干预措施
Boric Acid Suppository Group
Participants will use 600 mg Boric Acid Gelatin Capsules (The Killer®) once daily for 7 consecutive days when they feel they are experiencing any signs of vaginal imbalance such as vaginal malodor, irritation, and/or itching.
干预措施: Boric Acid Suppository (Dietary Supplement)
结局指标
主要结局
Vaginal Health and Balance
时间窗: Baseline, and Day 8
Vaginal pH testing
Vaginal Health and Balance
时间窗: Baseline, Day 3, Day 7, and Day 8
Evaluation of vaginal health and balance via participant questionnaires.
次要结局
- Participant Perception of Product Convenience(Day 3 and Day 7)