Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
研究概览
简要总结
This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms.
It is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings.
A total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months.
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
盲法说明
Open-label observational single-group
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18-36
- •Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, bloating, mood swings, or fatigue
- •May experience regular or irregular menstrual cycle
- •May be on birth control
- •Must know or can estimate the date of the next cycle/period
- •May find blood clots in menstrual blood
- •Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)
- •Following a stable, consistent diet regimen
- •Follow 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
- •Agree 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)
- •Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions
- •Willingness to adhere to the dietary supplement regimen
- •Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period
- •Is able to communicate in English
- •Is willing and able to share feedback via the used technology portal
- •Must provide written informed consent (ICF)
排除标准
- •Don't experience a menstrual cycle
- •Can't estimate the onset of their next menstrual cycle
- •Don't experience menstrual cramping
- •Follow an extreme diet intervention
- •Experienced severe weight loss in the past 3 months prior to study participation
- •Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle
- •If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
- •Food intolerances/allergies that require an EpiPen
- •Known allergic reaction to any of the test product ingredients
- •Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
- •Previous users of Elix Cycle Balance
- •Having more than 3 alcoholic drinks a day
- •Have been diagnosed with the following conditions: PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
- •Not been on a stable dose of birth control for the past 6 months
结局指标
主要结局
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
时间窗: Baseline, Month 1, Month 2, Month 3
Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
时间窗: Baseline, Month 1, Month 2, Month 3
Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
时间窗: Baseline, Month 1, Month 2, Month 3
Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.
次要结局
- Reduction in Mood Swings. [Time Frame: Baseline to Week 12](Baseline, Month 1, Month 2, Month 3)
- Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Headaches. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Backaches. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Body Aches. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Bloating. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Relief From Breast Tenderness. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)
- Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3](Baseline, Month 1, Month 2, Month 3)