An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
研究概览
简要总结
Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.
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 between 18-40 years of age.
- •Must be in good health with no significant chronic conditions and a BMI under
- •Must experience period pain and other PMS symptoms.
- •Must have a regular menstrual cycle with a bleed week.
- •If using hormonal contraception, must do so for at least three months
- •If using oral contraception, must allow for bleed week.
- •Must be able to predict their bleed week.
- •Willing to abstain from strenuous exercise 24 hours before each of the three blood draws in this trial.
排除标准
- •Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
- •Anyone with known severe allergic reactions.
- •Anyone with a previous negative experience with acetaminophen.
- •Unwilling to follow the study protocol.
- •Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
- •Anyone who uses other supplements for period pain and PMS symptoms.
- •Current use of an extended activity hormonal contraception (examples include Depo-provera or Nexplanon.
研究组 & 干预措施
Single Group
Single-group crossover trial with 100 total participants. Participants will use Pamprin Botanicals during their first period and both Pamprin Botanicals and over-the-counter Pamprin Menstrual Relief during their second period.
干预措施: Pamprin Botanicals (Other)
Single Group
Single-group crossover trial with 100 total participants. Participants will use Pamprin Botanicals during their first period and both Pamprin Botanicals and over-the-counter Pamprin Menstrual Relief during their second period.
干预措施: Pamprin Botanicals + Pamprin Menstrual Pain Relief (Combination Product)
结局指标
主要结局
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
时间窗: 60 days
Menstrual cycle symptoms will be measured via study-specific questionnaires.
次要结局
- Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)](60 days)