NCT06763809已完成不适用
A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
Semaine Health2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Change in Premenstrual Syndrome (PMS) Symptom Severity
研究概览
简要总结
This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 18+ years of age.
- •Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under
- •Must experience at least five of the following symptoms during their menstrual cycle:
- •Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances
- •Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week.
- •If using hormonal contraception, must do so for at least three months before starting the trial, and remain consistent with taking it as per healthcare provider instructions during the study.
- •If using hormonal contraception, must allow for a bleed week every month.
- •Must agree to avoid cannabis, CBD, ashwagandha, and supplements other than multivitamins or protein powders for 24 hours prior to the study, and during the full study duration.
- •Willing to refrain from OTC pain medications or supplements to target period-related symptoms during the study period.
- •Must live in the United States.
排除标准
- •Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
- •Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures.
- •Anyone diagnosed with Graves disease, Hashimotos or taking any medication for their thyroid.
- •Anyone who has undergone any surgeries or invasive treatments in the last six months, or is planning to during the study period.
- •Anyone with any allergic reactions requiring the use of an Epi-pen.
- •Anyone with known severe allergic reactions, or history of allergy or intolerance to ingredients found in over-the-counter dietary, vitamin or herbal supplements.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
- •Anyone with known allergies to nightshades (e.g., eggplant, tomato, bell pepper, potato).
- •Unwilling to follow the study protocol.
- •Anyone pregnant, breastfeeding, or trying to conceive currently or for the duration of the study.
- •Participants will self-report that they are not pregnant.
- •Current use of an extended activity hormonal contraception (examples include Depo-Provera injection, Nexplanon implant, or hormonal intrauterine devices (IUDs)).
- •Currently participating in any other clinical study or planning to at any point during this study's duration.
- •Anyone who has an alcohol dependency, regularly uses cannabis, or is using illicit drugs.
- •Anyone with a history of substance abuse.
- •Anyone who regularly takes supplements that might reduce inflammation or is planning to at any point during the study period.
- •Anyone currently taking prescription pain medication for any indication.
- •Anyone who is currently taking, or planning to take during the study period, any medications, supplements or products targeted at improving Premenstrual Syndrome symptoms.
结局指标
主要结局
Change in Premenstrual Syndrome (PMS) Symptom Severity
时间窗: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Evaluate the effectiveness of the PMS capsule and gummy in alleviating symptoms associated with PMS, using the validated Menstrual Symptom Questionnaire (MSQ). The MSQ assesses 24 symptoms with scores ranging from 1 (never) to 5 (always), where a higher score indicates greater symptom severity.
次要结局
- Participant Perception of PMS Symptom Relief(From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline))
研究者
研究点 (2)
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