Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- disappearance rate of dyspepsia
研究概览
简要总结
This is a randomized double-blind placebo controlled trial aim to compare the efficiency of genuine regional and non-genuine regional Rhizoma Atractylodis in treating functional dyspepsia. This study will also observe the clinical safety of genuine regional Rhizoma Atractylodis.The trial will be conducted in Xiyuan Hospital of China Academy of Chinese Medicine Sciences and Dongzhimen Hospital of Beijing University of Chinese Medicine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the FD Rome Ⅲ diagnosis standard;
- •Meeting TCM differentiated diagnosis standard of the spleen deficiency with dampness pattern;
- •Without taking any medicines affecting gastric motility in the recent 14 days;
- •Between 18 and 65 years old;
- •Voluntary participation in the trial and signing informed consent.
排除标准
- •Combined irritable bowel syndromes; combined peptic ulcer, erosive gastritis, atrophic gastritis, abdominal surgery history, gastric mucosa with severe dysplasia or pathological diagnosis of suspected malignant transformation; combined gastroesophageal reflux disease, irritable bowel syndrome with overlapping syndromes.
- •Patient whose differentiation is not clear or who doesn't belong to the spleen deficiency with dampness pattern.
- •Women in pregnancy, breastfeeding or have fertility plans recently; the legally disabled (blind, deaf, dumb, mental retardation, mental disorders, physical disability)
- •Patients with endocrine and metabolic diseases such as connective tissue diseases, diabetes, menopausal syndromes; patients combined with heart rate disorder, severe diseases in cardiovascular, brain, liver, lung, kidney and hematopoietic systems, acute and chronic infectious diseases, malignant tumors, mental illness.
- •Allergy to the trial drug.
- •With suspected or definite alcohol, drug abuse history.
研究组 & 干预措施
genuine regional Rhizoma Atractylodis
Granules of genuine regional Rhizoma Atractylodis:
Maozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., orally administration, 9g per time, 3 times a day.
干预措施: genuine regional Rhizoma Atractylodis (Maozhu granule) (Drug)
non-genuine regional Rhizoma Atractylodis
Granules of non-genuine regional Rhizoma Atractylodis (Luotian, Hubei province) :
Luozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., orally administration, 9g per time, 3 times a day.
干预措施: genuine regional Rhizoma Atractylodis (Maozhu granule) (Drug)
placebo
placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day.
干预措施: genuine regional Rhizoma Atractylodis (Maozhu granule) (Drug)
结局指标
主要结局
disappearance rate of dyspepsia
时间窗: Eight weeks
The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.
次要结局
- The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ(Eight weeks)
- Nepean Dyspepsia Index, NDI(Eight weeks)
研究者
Yanming Xie
Executive director
China Academy of Chinese Medical Sciences