Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study
2026年6月3日 更新者：Miracle Wellness LLC
A Randomized, Sham Supplement- and Care-as-Usual-Controlled Study to Evaluate Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study
The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
920
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Principal Investigator
- 电话号码：443-220-3558
- 邮箱：info@migraceutics.com
学习地点
-
-
Maryland
-
Lutherville-Timonium、Maryland、美国、21093
- Natural Migraceuticals
-
接触：
- Principal Investigator
- 电话号码：443-220-3558
- 邮箱：info@migraceutics.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine.
- Being able to take oral supplements.
- Agreeing to maintain their regular lifestyle.
- Access to internet and telephone.
Exclusion Criteria:
- Pregnancy or lactation.
- Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition.
- Use of overlapping supplements or interacting medications.
- Known allergies to study ingredients.
- Daily use of alcohol, tobacco, or recreational drugs.
- Participation in any other clinical or interventional study within 30 days prior to baseline or concurrently.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Arm 1 - Care as usual (CAU)
|
|
|
假比较器：Arm 2 - Care as usual (CAU) + Reference dietary supplement
|
Reference comparator supplement, self-administered daily.
|
|
其他：Arm 3 - Care as usual (CAU) + Foundational dietary supplement
|
Foundational dietary supplement, self-administered daily.
|
|
其他：Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement
|
Foundational dietary supplement, self-administered daily.
Add-on dietary supplement, self-administered during the symptomatic migraine phase.
|
|
其他：Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement
|
Foundational dietary supplement, self-administered daily.
Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes from baseline in migraine-related quality of life
大体时间：Baseline, Month 1 through Month 6
|
Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score.
HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points).
Total scores can range from 36 to 78, with higher totals reflecting a more significant impact.
|
Baseline, Month 1 through Month 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of self-reported migraine days per month
大体时间：Baseline, Month 1 through Month 6
|
The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine.
|
Baseline, Month 1 through Month 6
|
|
Distribution of participants experiencing changes in monthly migraine days
大体时间：Baseline, Month 1 through Month 6
|
Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline.
|
Baseline, Month 1 through Month 6
|
|
Use of over-the-counter or prescription migraine or headache medication
大体时间：Baseline, Month 1 through Month 6
|
Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication
|
Baseline, Month 1 through Month 6
|
|
Migraine symptoms participants experienced
大体时间：Baseline, Month 1 through Month 6
|
Mean monthly number of migraine symptoms.
|
Baseline, Month 1 through Month 6
|
|
Self-reported migraine symptom severity
大体时间：Baseline, Month 1 through Month 6
|
Self-reported migraine symptom severity scores.
Participants rate each of their reported symptoms on a scale from 0 to 10 how bad these symptoms were at their worst.
0: I did not have this symptom, and 10: it was the worst imaginable
|
Baseline, Month 1 through Month 6
|
|
Mean number of migraine hours
大体时间：Baseline, Month 1 through Month 6
|
Mean number of hours in the past 30 days on which a migraine occurred
|
Baseline, Month 1 through Month 6
|
|
Number of missed work and/or school days due to migraine
大体时间：Baseline, Month 1 through Month 6
|
Number of missed work and/or school days per month (self-reported)
|
Baseline, Month 1 through Month 6
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in systemic CGRP concentrations
大体时间：Baseline, Month 1 through Month 6
|
Mean systemic CGRP concentrations.
|
Baseline, Month 1 through Month 6
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月8日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.