NCT07018479已完成不适用
Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
VINABAS FORMULATIONS SL1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年7月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in PMS Symptoms
研究概览
简要总结
This virtual single-group study evaluates the effects of the FemmeBalance supplement on symptoms of premenstrual syndrome (PMS) over four menstrual cycles. The study involves daily intake of the supplement, regular questionnaires, and skin photo submissions for dermatological grading.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18-
- •Self-reported symptoms of PMS for at least three consecutive months, including but not limited to pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness.
- •Generally healthy and not living with any uncontrolled chronic disease.
- •Has a regular menstrual cycle between 21 and 35 days in length.
- •Willing to maintain the same diet, sleep schedule, and activity level for the duration of the study (at least 16 weeks).
- •Own a smartphone with a camera.
- •Must reside in the United States.
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with known severe allergic reactions that require the use of an Epi-pen or any allergies to any of the product ingredients.
- •Women who are pregnant, breastfeeding, or trying to conceive.
- •Anyone who is unwilling or unable to follow the study protocol.
- •Anyone previously diagnosed with premenstrual dysphoric disorder (PMDD), endometriosis, or any cancer of the reproductive system.
- •Anyone who is peri- or post-menopausal.
- •Anyone who is currently on hormonal birth control or who has been on hormonal birth control in the last three months.
- •Anyone who is taking any products, medication, or supplements that target the symptoms of PMS.
- •Anyone who has undergone any surgeries or invasive treatments in the last six months or who is planning on undergoing any in the study duration.
- •Anyone who has had any major illness in the last three months.
- •Anyone who is currently undergoing, or who plans to undergo in the study period, any procedures relating to reproductive health and/or the menstrual cycle, e.g., a hysterectomy, ovary removal, or similar procedure.
- •Anyone who suffers from amenorrhoea or irregular periods (<21 days or >35 days apart on average).
- •Anyone who is currently participating in or who plans to participate in another trial during the study period.
- •Anyone with a history of substance abuse.
- •Anyone who smokes or who has been a smoker in the past three months.
研究组 & 干预措施
FemmeBalance Supplement Group
Experimental
Two capsules daily of FemmeBalance, containing Sabal Serrulata, NAC, turmeric extract, chasteberry extract, vitamin B5, black pepper extract, and excipients.
干预措施: FemmeBalance Supplement Group (Dietary Supplement)
结局指标
主要结局
Change in PMS Symptoms
时间窗: Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Change in self-reported symptoms of premenstrual syndrome, including pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness, assessed using validated questionnaires (PSST and study-specific tools).
次要结局
- Participant Perception of Supplement Effectiveness(Day 7 of each menstrual cycle over 4 cycles (~16 weeks))
研究者
研究点 (1)
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