A Clinical Trial to Evaluate the Effects of Super Liver Liquid Drops on Gut Health, Digestive Comfort, and Daily Energy Levels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
This is a decentralized (fully virtual), single-group, open-label, prospective clinical trial evaluating the effects of Super Liver Liquid Drops, a liquid botanical dietary supplement, on gut health, digestive comfort, energy levels, and overall well-being over 12 weeks. All 35 enrolled participants will self-administer 2 mL of Super Liver Liquid Drops daily (2 droppers filled to 1 mL each) in the morning with breakfast for the full 12-week intervention period.
Participants will complete validated questionnaires and self-reported assessments at Baseline, Week 2, Week 4, Week 8, and Week 12 via the Citruslabs study platform. All study activities will be conducted remotely.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female.
- •Be aged 30-65 years (inclusive) at the time of enrollment.
- •Over the past four weeks, has had concerns regarding low energy levels and at least two of the following: Bloating, Digestion, Irregular Bowel movements, Brain fog.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- •Willing and able to follow the study protocol as described.
- •Willing to maintain their current diet, exercise routine, and sleep patterns, for the duration of the trial.
- •If taking other over-the-counter supplements or herbal remedies is willing to maintain this routine without introducing any other new products for the study duration.
- •Resides in the United States.
- •Willing to follow the study protocol as described.
排除标准
- •Known allergy or sensitivity to any of the study product ingredients (milk thistle, dandelion, yellow dock, turmeric, ginger, chicory/inulin, berberine).
- •Known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries.
- •Known history of gallbladder disease or bile duct obstruction.
- •Has a chronic health condition that could impact participation in this study, such as oncological or psychiatric disorders.
- •Has a planned surgery in the next 12 weeks.
- •Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
- •Known history of substance abuse.
- •Currently, or was in the past 3 months, a smoker.
- •Currently participating in or planning to participate in another research study during the study period.
结局指标
主要结局
Change in Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Baseline to Week 12
Change from baseline to Week 12 in gastrointestinal symptom severity as assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores indicate greater gastrointestinal symptom severity.
次要结局
- Change in Self-Reported Energy Level Score(Baseline to Week 12)
- Change in Self-Reported Brain Fog Score(Baseline to Week 12)
- Change in Self-Reported Mood Stability Score(Baseline to Week 12)
- Change in Self-Reported Sleep Quality Score(Baseline to Week 12)
- Change in Self-Reported Skin Clarity Score(Baseline to Week 12)
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)(Continuous monitoring over 12 weeks)