Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in 7 point Likert scale scores
研究概览
简要总结
To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with no abnormal clinical manifestations;
- •Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
- •Aged between 18 and
- •Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
- •Subjects are informed and sign informed consent voluntarily;
- •Have certain reading ability.
排除标准
- •Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
- •Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);
- •Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
- •Those with a history of allergy to related drugs or severe food allergy used in the research.
- •The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.
研究组 & 干预措施
Non-erosive reflux disease control group
干预措施: The placebo of tong-jiang granules (Drug)
Non-erosive reflux disease test group
干预措施: tong-jiang granules (Drug)
Diarrhea-type irritable bowel syndrome test group
干预措施: Chang 'an II Recipe (Drug)
Control group with diarrheal irritable bowel syndrome
干预措施: The placebo of Chang 'an II Recipe (Drug)
结局指标
主要结局
Changes in 7 point Likert scale scores
时间窗: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms)
Changes in irritable bowel syndrome symptom severity scale scores
时间窗: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard.
次要结局
未报告次要终点