The Effect of Mastiha Products on Functional Dyspepsia. a Randomised Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in Leuven Postprandial Distress Scale (LPDS)
研究概览
简要总结
The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.
详细描述
Functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. Its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. Mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. In the present study, the investigators aim to determine whether Mastiha capsules or Mastiha water have a better effect on the improvement of functional dyspepsia symptoms. Therefore, the investigators designed a randomized, three-way cross-over clinical trial. Fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. The three treatments will be: Mastiha capsules, Mastiha water or Mastiha free treatment. The primary outcome, which will be assessed by intention to treat, will be the Leuven Postprandial Distress Scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the European Medicines Agency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional dyspepsia diagnosis according to
- •Rome criteria
- •negative urea breath test for Helicobacter pylori
- •upper gastrointestinal tract endoscopy with biopsy
排除标准
- •organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome
- •pregnancy or lactation
- •history of abdominal surgery or actinotherapy
- •mental illness
- •Severe impairment of heart, liver, or kidney function or respiratory function
- •Alcohol overuse
结局指标
主要结局
Changes in Leuven Postprandial Distress Scale (LPDS)
时间窗: 1 month
The change in Leuven Postprandial Distress Scale will be evaluated at follow-up. LPDS minimum score is 0 and maximum 32. Higher scores mean a worse outcome.
次要结局
- Change in quality of life(1 month)
- Use of medicines(1 month)
- Change in anxiety(1 month)
研究者
Andriana C. Kaliora
Professor
Harokopio University