A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CanXida
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12]
研究概览
简要总结
This is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Candida microbiome testing will be conducted via stool sample at Baseline and Week 12.
The participants will all be blinded to the name of the test brand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study will be double-blinded in that the study participants and the Citruslabs team will be blinded to the intervention or product allocation. Only the sponsor will know which product contains the active ingredients. After the study analysis is complete, the allocation will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-
- •Self-reported recurrent vaginal issues, including:
- •Itching and irritation in and around the vaginal area.
- •Burning sensation during urination or sexual intercourse.
- •Abnormal discharge (e.g. thicker, white, and curd-like in appearance, odorless, or with a mild yeasty smell.
- •Redness and swelling of the vulva and surrounding skin
- •Pain or discomfort in the vaginal area or lower abdomen.
- •Urinary tract infections
- •Vaginal thrush
- •May also experience issues with fatigue, lethargy, and gut or digestive issues.
- •Willing to provide two stool samples during the study.
- •Willing to adhere to the study protocol.
- •Willing to avoid introducing any products or any new forms of regular medication or supplements that target candida overgrowth, gut health, or vaginal health for the duration of the study.
排除标准
- •Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
- •Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
- •Currently taking any antibiotics or will be during the trial period.
- •Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
- •Women who are pregnant, breastfeeding, or attempting to become pregnant.
- •Having any planned invasive medical procedures during the study period.
- •Currently participating in any other clinical study.
- •History of substance abuse.
- •Unwilling to follow the study protocol.
结局指标
主要结局
Changes in growth of candida in the gut. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via gut microbiome analysis. Participants will provide a stool sample for the analysis.
次要结局
- Changes in vaginal health symptoms. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in self-reported energy levels. [Timeframe: Baseline to Week 12](12 weeks)
- Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12](12 weeks)
- Changes in scores on the Bristol Stool Scale. [Timeframe: Baseline to Week 12](12 weeks)