A Randomized,Double-blind,Placebo-controlled,Multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
试验速览
- 阶段
- 2 期
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Percentage of Participants Who Are Composite Responders Consistency Scores
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.
详细描述
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.
Patients report their IBS-related symptoms daily from run-in until end of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
- •It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
- •Male or female aged 18 to 65 years (including the boundary value);
- •The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
- •IBS-SSS score>175;
- •Signed informed consent voluntarily.
排除标准
- •Patients with IBS-C、IBS-M or IBS-U；
- •Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
- •Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
- •Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
- •Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
- •With history of abdominal surgery (e.g., cholecystectomy);
- •Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
- •Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
- •Taking emergency medication in the run-in period；
- •Pregnant or lactating women；
- •Those who are allergic to the test drug, emergency drug and its ingredients；
- •Suspected or confirmed history of alcohol and drug abuse;
- •Patients who participated in other clinical trials within one month before enrollment;
- •The researchers believe that others are not suitable for clinical trials.
研究组 & 干预措施
Changkang Granules
Changkang Granules
干预措施: Changkang Granule (Drug)
Changkang Placebo Granules
Changkang Placebo Granules
干预措施: Changkang Placebo Granule (Drug)
结局指标
主要结局
Percentage of Participants Who Are Composite Responders Consistency Scores
时间窗: 8 week
Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week. 1. Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; 2. Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
次要结局
- Change from baseline to each week during follow up for IBS-symptoms abdominal pain；(8 week)
- Change from baseline to each week during follow up for IBS-symptoms Defecation frequency(8 week)
- Percentage of Participants Who Are Responders in Abdominal Pain Scores(8 week)
- Change from baseline to each week during follow up for IBS-symptoms bloating(8 week)
- Change from baseline to each week during follow up for IBS-symptoms urgency(8 week)
- Percentage of Participants Who Are Responders in Stool Consistency Scores(8 week)
- Change from baseline to each week during follow up for IBS-symptoms stool consistency;(8 week)
- Disappearance rate of traditional Chinese Medicine（TCM）symptom(8 week)