A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG
研究概览
简要总结
This is a hybrid, two-arm, triple-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of the Stasis supplement on reducing oxidative stress, cortisol levels, and side effects associated with stimulant medications used for ADHD over a three-month period in adults.
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, Care Provider, Outcomes Assessor)
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-55 years
- •Currently prescribed stimulant medication for ADHD
- •Experiencing: sleep difficulty, irritability, anxiety, brain fog
- •Stable medication dose ≥3 months
- •Healthy with no uncontrolled chronic conditions
- •Stable on supplements ≥3 months if applicable
- •US resident
- •Willing to maintain current habits
排除标准
- •Chronic conditions (e.g. cancer, mental illness)
- •Use of psychiatric medications besides stimulants
- •Pregnancy, breastfeeding, thyroid, liver, kidney conditions
- •Recent smokers or heavy alcohol use
- •Night shift workers
- •Participation in other clinical trials
- •Allergies to product ingredients
研究组 & 干预措施
Stasis Supplement
干预措施: Stasis Daytime and Nighttime (Dietary Supplement)
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG
时间窗: Baseline and Month 3
Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers: hs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples
Change in cortisol levels
时间窗: Baseline and Month 3
Serum cortisol concentration measured via blood draw.
次要结局
- Change in sleep quality(Baseline, Month 1, Month 2, and Month 3)
- Change in irritability(Baseline, Month 1, Month 2, and Month 3)
- Change in focus(Baseline, Month 1, Month 2, and Month 3)
- Change in sociability(Baseline, Month 1, Month 2, and Month 3)
- Change in self-reported mood(Baseline, Month 1, Month 2, and Month 3)
- Change in self-reported stress(Baseline, Month 1, Month 2, and Month 3)
- Change in self-reported appetite(Baseline, Month 1, Month 2, and Month 3)
- Change in blood levels of Vitamin C(Baseline and Month 3)
- Change in blood levels of CoQ10(Baseline and Month 3)