Xiang-sha-liu-jun Granules as an Herbal Formula for the Treatment of Postprandial Distress Syndrome(PDS): a Prospective, Double-blinded, Randomized and Placebo-controlled,Three-center Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- change of postprandial discomfort severity Scale
研究概览
简要总结
Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i)Aging between 18 and 75 years, able to read and write Chinese;
- •ii)have a TCM diagnosis of spleen deficiency and qi stagnation pattern;
- •iii) Having normal esophagogastroduodenoscopy results within 6 months;
- •iv) Having normal liver and renal function confirmed by blood tests within 3 months;
- •v) Being diagnosed as PDS of FD by a specialist consultation;
- •vi）Receiving no other treatments during the study;
- •vii）Voluntarily agreeing with the study protocol and signing a written informed consent.
排除标准
- •i)Having peptic ulcer or gastroesophageal reflux disease confirmed by esophagogastroduodenoscopy;
- •ii) Having obvious signs of irritable bowel syndrome;
- •iii) Having alarm symptoms (weight loss, black or tar stool, or dysphagia);
- •iv) Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness;
- •v) Having had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago;
- •vi) Pregnant or breastfeeding;
- •vii) Being taking drugs which may affect the gastrointestinal tract; a minimum wash-out period of two weeks is required before participating in the trial;
- •viii) Having a problem of malabsorption or maldigestion;
- •ix) Having a history of allergies to the studied drugs and food;
- •x) Having difficulties in attending the trial (such as paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy);
- •xi) Unwilling to sign the informed consent.
研究组 & 干预措施
placebo
Participants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed.
干预措施: placebo (Drug)
Xiang-sha-liu-jun granules
Participants will orally take the herbal formula granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed.
干预措施: Xiang-sha-liu-jun granules (Drug)
结局指标
主要结局
change of postprandial discomfort severity Scale
时间窗: Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
次要结局
- gastric emptying(gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine)
- global impression scale(global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine)
- SF-36 questionnaire(SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine)