Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Weekly response rate of abdominal pain and diarrhea
研究概览
简要总结
The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are:
- Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients?
- Is Changchangning Tablet safe for the treatment of IBS-D?
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
- •Meet IBS-D Rome IV diagnostic criteria;
- •Age between 18 and 65 years old (including boundary value), regardless of gender;
- •IBS symptom severity scale (IBS-SSS) scores > 175 points;
- •The weekly average score of abdominal pain in screening period is ≥ 3 points (The most severe abdominal pain in the past 24 hours every day, the pain score was 11 grades (0-10), NRS-11; Also the number of days of the stool character classification (Bristol stool scale) is type 6 or 7 ≥ 2 in a week;
- •Patients who voluntarily accept the program's plan of the project and signs the informed consent form.
排除标准
- •Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;
- •Patients are affected by factors such as intellectual disorder, mental disorder and language;
- •Patients with gastrointestinal organic diseases or with malignant tumors, such as pancreatitis, intestinal adenoma (excluding polypectomy for more than half a month), intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease, intestinal tuberculosis, etc;
- •Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;
- •Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;
- •Allergic constitution or allergic to the components of the studied drug;
- •Pregnant or lactating women, and women with recent fertility plans;
- •Previous abdominal or pelvic surgery, such as cholecystectomy;
- •Patients with positive fecal occult blood;
- •During the screening period, drugs that affect gastrointestinal motility and function cannot be stopped, including parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta, etc; Opioid preparations, etc;
- •Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;
- •IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;
- •Those who regularly drink alcohol within 6 months before screening, i.e., drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol);
- •Those who have participated in or are currently participating in other clinical trials within 1 month before screening;
- •The researcher believes that there are patients who are not suitable for inclusion.
研究组 & 干预措施
Changyanning group
Changyanning tablet: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks.
干预措施: Changyanning tablet (Drug)
Placebo group
Changyanning tablet placebo: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks.
干预措施: Changyanning tablet placebo (Other)
结局指标
主要结局
Weekly response rate of abdominal pain and diarrhea
时间窗: 8 weeks (after treatment)
The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%.
次要结局
- Weekly response rate of diarrhea(2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks)
- IBS quality of life (IBS-QOL) scores(6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）)
- Weekly response rate of abdominal pain and diarrhea(2 weeks, 4 weeks, 6 weeks, 12 weeks)
- Weekly response rate of abdominal pain(2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks)
- IBS symptom severity scale（IBS-SSS）scores(2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks)
- Stool frequency(2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks)
研究者
Mei Han
Principal Investigator
Beijing University of Chinese Medicine