NCT07078682招募中不适用
An Open-Label, Single-Group Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
Zenchi, Inc.2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in uterine fibroid-related symptom severity
研究概览
简要总结
This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be female.
- •Be aged 20-
- •BMI 18.5 - 24.9 kg/m2
- •Self-reported prior diagnosis of uterine fibroids.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- •Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, bloating, mood swings, or fatigue.
- •Self-reported menstrual cramps during their cycle, for the past six months minimum.
- •If taking hormonal birth control, has been doing so consistently for at least three months, and experiences a menstrual cycle with a period.
- •If taking other oral over-the-counter supplements or herbal remedies, has been consistently taking these for at least three months prior to starting the study, and is willing to maintain this routine for the study duration.
- •Willing to refrain from introducing any products or any new forms of medication or supplements for the study duration.
- •Willing to refrain from any other dietary supplements or herbal remedies targeting the menstrual cycle during the study period.
- •Willing to refrain from any new vaccines during the 6 month period.
- •Follows a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen.
- •Agrees to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise).
- •If using any other interventions, such as massage, chiropractic medicine, or acupuncture, agrees not to increase or decrease the number of these other interventions during the study period.
- •Resides in the United States.
排除标准
- •Does not experience a regular menstrual cycle (21-35 days).
- •Does not experience menstrual cramping.
- •Follows an extreme diet intervention such as dry fasts, water fasts, or ketogenic diets.
- •Anyone who has experienced significant weight loss in the past three months prior to study participation.
- •Unwilling to stop the use of any medication or herbal remedies/supplements that can affect the menstrual cycle.
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with known severe allergic reactions.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •Anyone unwilling to follow the study protocol.
- •Has stopped, started, or changed hormonal birth control in the past three months.
- •Previous users of Elix Cycle Balance.
- •Anyone who is currently a smoker or has been a smoker in the past 3 months.
- •Anyone who has been diagnosed with the following conditions: PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's thyroiditis, Grave's disease (and any other thyroid disorders), hyperprolactinemia, Cushing's disease, congenital adrenal hyperplasia, anorexia, bulimia, orthorexia, binge eating, any other eating disorder.
- •History of endocrine disorders such as thyroid disorder, Type 1 or 2 diabetes, or other.
- •History of hypertension, hyperlipidemia, or previous venous embolism.
- •Overweight/obesity (BMI > 25 kg/m2).
- •Women with other causes of chronic pelvic pain, including infectious disease, gastrointestinal, psychological disorders, fibromyalgia, and chronic fatigue syndrome.
- •Hysterectomy, myomectomy, or bilateral salpingo-oophorectomy or other gynecological medical or surgical treatment in the last 6 months.
- •History of an abnormal pap smear.
- •History of neoplasia of gynecological origin and/or existence of uterine malformations.
- •Chronic urinary tract infections or diagnosed functional gastrointestinal conditions like IBS, IBD, Crohn's disease, or ulcerative colitis.
- •Currently partaking in another research study or will be partaking in any other research study for the next 24 weeks, or at any point during this study's duration.
- •Consume more than 5 alcoholic drinks per week
- •Had a vaccine in the last 3 months
结局指标
主要结局
Change in uterine fibroid-related symptom severity
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Measured as change in menstrual pain and bleeding volume using the validated Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) total and subscale scores.
次要结局
- Change in fibroid-related health-related quality of life domains(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
研究者
研究点 (2)
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