Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Abdominal Pain Intensity
研究概览
简要总结
This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol type). And secondary endpoints included overall symptoms sensory scores, defecation frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale). After the end of the treatment period, the participants whose pain intensity and stool type are effective subjects into a randomized withdrawal period, analysis and comparison of the difference between treatment group and placebo group withdrawal rate and curative effect index score reduces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Man or woman, aged 18 to 65 years, inclusive.
- •Based on the Roman III diagnostic criteria for diagnosis of IBS-D subjects, recurrent abdominal pain or discomfort (hard to describe the discomfort of pain), monthly attack within the past 3months at least 3 days. With two or more of the following three kinds of symptoms:
- •At least a portion of the time abdominal pain or defecate increase when discomfort.
- •At least a portion of the time abdominal pain or the row of loose stools when discomfort.
- •At least a portion of the time abdominal pain or discomfort improved after defecation.
- •Symptoms for at least 6 months before diagnosis
- •Screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week.
- •Voluntarily signed the informed consent form
排除标准
- •The absorption of any known adverse
- •History of gastrointestinal surgery ( not including appendectomy)
- •History of organic gastrointestinal diseases: IBS, cancer etc.
- •History of chronic diseases: anemia (hemoglobin<90g/L), pulmonary tuberculosis, diabetes or cardiovascular, liver, kidney, brain, and hematopoietic system and other serious diseases and psychiatric patients, AST(aspartate aminotransferase), ALT (alanine aminotransferase)> 1.5 times, BUN (blood urea nitrogen)> 1.2 times, Cr > 1.0 times normal.
- •The disease of lactose intolerance, gallstones, endometriosis, easily confused with IBS symptoms of ;
- •Progressive weight loss;
- •Concomitant medication is unable to stop but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology;
- •Concomitant medication use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as parasympathetic inhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc;
- •Other researchers think not suitable for the list;
研究组 & 干预措施
Starch capsule
During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper.
干预措施: placebo (Drug)
N-acetyl-D-glucosamine
During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken.
干预措施: N-acetyl-D-glucosamine (Drug)
结局指标
主要结局
Abdominal Pain Intensity
时间窗: one and a half years
As measured by numerical rating scale
Stool Consistency
时间窗: one and a half years
As measured by Bristol ' s scale
次要结局
- defecation frequency(one and a half years)
- abdominal distension(one and a half years)
- General symptoms feel grading(one and a half years)
- mucous stool(one and a half years)
- life quality parameters(one and a half years)
研究者
Liujunkang
The director of microecological pharmaceutical research
Third Military Medical University