A Non-randomized, Single-Arm, Open-Label Pilot Study to Evaluate the Efficacy and Safety of MOLEQURE- Gastrointestinal Health in Adults with Functional Gastrointestinal Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean change in composite GI symptom score using a GSRS from baseline to different study visits.
研究概览
简要总结
The primary objective is to evaluate the efficacy of MOLEQURE-Gastrointestinal Health in improving gastrointestinal symptoms such as abdominal bloating, indigestion, acidity, discomfort, altered appetite, and bowel irregularity after 28-days of 24 patients who are under clinical diagnosis of Functional Gastrointestinal Disorder (FGID). The mean change in the composite GI symptom score using a GSRS, the Gastrointestinal Quality of Life Index (GI-QoLI), and laboratory safety parameters (CBC, liver, and kidney function tests) will be assessed after 28 days of treatment with MOLEQURE-Gastrointestinal Health Capsule, twice daily before meals. The statistical analysis for this study will include descriptive statistics to summarize demographic and baseline characteristics of the participants. Within-group comparisons of efficacy variables will be conducted using paired t-tests or Wilcoxon signed-rank tests, depending on the data distribution and study time points. Adverse events and other categorical data will be analyzed using frequency and percentage distributions. A p-value of <0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female subjects aged above 18 years with clinical diagnosis of Functional Gastrointestinal Disorder (FGID).
- •Subjects with mild to moderate gastrointestinal clinical symptoms, based on a GSRS.
- •Subjects with stable dietary and lifestyle patterns for the last 4 weeks
- •Willingness to comply with study procedures and provide written informed consent.
排除标准
- •Use of antibiotics, probiotics, prebiotics, or GI-targeting supplements in past 4 weeks
- •Subjects with organic GI diseases (IBD, celiac disease, peptic ulcer disease, GI malignancy)
- •History of gastrointestinal surgery within the past year
- •Severe psychiatric illness or any systemic disease deemed unsafe by the investigator
- •Pregnant or lactating women, or women planning to become pregnant during the study period.
- •Known allergy or hypersensitivity to any component of the investigational product
- •Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days.
结局指标
主要结局
Mean change in composite GI symptom score using a GSRS from baseline to different study visits.
时间窗: 28 days.
次要结局
- 1) Mean change in the Gastrointestinal Quality of Life Index (GI-QoLI) from baseline to end of the study.(28 days.)
研究者
Srikanta Pandit
J. B. Roy State Ayurvedic Medical College and Hospital