Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 5
- 主要终点
- change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
研究概览
简要总结
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Chang'an I Recipe
Patients in this group were administered the Chang'an I Recipe for 8 weeks.
干预措施: Chang'an I Recipe (Drug)
Placebo
Patients in this group were administered the placebo for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
时间窗: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Score less than 75 points was considered as in remission, 75\~175 as mild, 175\~300 as moderate, and over 300 as severe.
次要结局
- Serum markers regarding liver and kidney function(at baseline and 8 weeks.)