Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
研究概览
简要总结
The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy.
Null hypothesis is that VM does not influence FD symptoms.
详细描述
50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Functional Dyspepsia
排除标准
- •Diabetes Mellitus
- •Mental disturbance
- •Thyroid gland dysfunction
- •Intestinal, liver and biliary tract disease
- •Concurrent medications that could interact with GI function
- •Positive Helicobacter Pylori status
研究组 & 干预措施
Usual drug FD therapy + Visceral Manipulation
干预措施: Visceral Manipulation (Procedure)
Usual drug FD therapy
干预措施: PPIs and/or Domperidone (Drug)
结局指标
主要结局
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
时间窗: baseline, 1, 4 and 8 weeks after therapy start
次要结局
未报告次要终点