Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale
研究概览
简要总结
Diarrhea irritable bowel syndrome(IBS-D）has seriously affected health and quality of life of patients.It may be important pathogenesis in development and recurrence of the process of IBS-D,excessive endoplasmic reticulum stress (ERS) activated PERK(proteinkinaseR-like ERkinase，PERK)-eIF2a(eukaryotic translation initiation factor 2 alpha,eIF2a) pathway and damaged intestinal mucosal epithelial Barrier. Tongxieyaofang(TXYF) had obtained satisfactory effect in treating IBS-D in clinic and previous study, but it is unknown that herbal formula how to work.This project applies metabolomics method to detect plasma,urine and stool metabolites for patients before and after treatment, to determine the effects of the"multiple ingredients"of TXYF in body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients meeting the diagnostic criteria of Western medicine for IBS-D;
- •aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
- •voluntarily signed the informed consent;
- •local resident who could ensure follow-ups, with basic reading ability
排除标准
- •Patients with IBS-C, -M, and uncertain forms;
- •accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
- •gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renal insufficiency, and nervous system diseases);
- •undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
- •with history of abdominal surgery (e.g., cholecystectomy);
- •with an allergy history of tested drugs or severe allergy history of food;
- •pregnant and lactating female;
- •with a history of neurological or psychiatric disorders;
- •or participating in other clinical trial.
研究组 & 干预措施
Tongxieyaofang granule group
干预措施: Tongxieyaofang(granule) (Drug)
结局指标
主要结局
Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale
时间窗: IBS-SSS was evaluated by patients at 4th week
Patients are graded according to their own symptoms（abdominal pain，bloating，defecation satisfaction，the extent to which the disease affects the lives of patients，bowel movements）, the total score less than 75 points was considered as in remission, 75\~175 as mild, 175\~300 as moderate, and over 300 as severe. We will assess changes in patient scores before and after treatment to reflect the extent of disease remission.
Bristol stool form scale（BSFS）
时间窗: BSFS was evaluated by patients at 4th week
Different fecal types can reflect different intestinal transit times, the lower the score, the longer the transmission time; the higher the score, the shorter the transmission time. We will assess changes in scores before and after treatment to reflect the extent of disease remission.
次要结局
- SF-36(the MOS item short from health survey)Scale(SF-36 Scale was evaluated at 4th week)
- IBS-D PRO( patient reported outcomes) Scale(IBS-D PRO Scale was evaluated at 4th week)