Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Change in the severity of gastrointestinal symptoms
研究概览
简要总结
Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.
详细描述
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) have histamine intolerance symptoms affecting GI health and at least one other organ/system, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- •Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. This may include:
- •Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- •Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
- •Lack of reliable daily access to the internet
排除标准
- 未提供
研究组 & 干预措施
Active GI Health Product 1
Active GI Health Product 1
干预措施: Active GI Health Product 1 (Dietary Supplement)
Placebo GI Health Control
Placebo GI Health Control
干预措施: Placebo GI Health Control (Dietary Supplement)
结局指标
主要结局
Change in the severity of gastrointestinal symptoms
时间窗: 7 weeks
Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 15-105; with higher scores equaling greater severity)
次要结局
- Change in GI-related Quality of Life (QOL)(7 weeks)
- Change in rhinitis symptom control(7 weeks)
- Change in itch severity(7 weeks)