Multicenter Randomized Double-blind Placebo-controlled Clinical Trials to Evaluate the Clinical Efficacy and Safety of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment
试验速览
- 阶段
- 3 期
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Abdominal Pain Intensity
研究概览
简要总结
This study is a randomized double-blind placebo-controlled clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment group, 360 for placebo group) in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS(numerical rating scale) 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 (12 weeks), follow-up period (2 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, defecation urgency and quality of life parameters (IBS-QOL scale).
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
- 是
入选标准
- •Voluntarily signed the informed consent form.
- •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 accompanied with abdominal discomfort or not, 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 per week.
- •During the screening period，patients should answer the questions of electronic log completely following the requirements for 10days or more.
- •Patients are willing to stop drugs for abdominal symptoms or diarrhea which are in violation of the scheme, and take medicine prescribed in the scheme.
- •Patients agree to not change the lifestyle significantly that may affect the symptoms of IBS-D from signing up the Informed Consent Form to the last experiment.
- •The illness recured after a normal colonoscopy report within one year that was provided by this hospital or a grade first class teaching hospital, include polyp of colon (less than 3mm,the number of less than 5) patients who taked therapeutic endoscopy and recurrenced within one year; or those that get a normal colonoscopy report in this hospital or a grade first class teaching hospital before screening but have a history of bowel preparation, should be chosen when next attack.
排除标准
- •History of organic gastrointestinal diseases: Chronic pancreatitis (cp), inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, gastrointestinal tumor, or other organic diseases etc.
- •History of abdominal and pelvic surgery ( not including appendectomy and intestinal polyposis (<3mm) after treatment within one year ).
- •The non-intestinal disease of digestive system such as Peptic ulcer, tuberculous peritonitis, cirrhosis etc.
- •Heart, lung, kidney and other important organs have severe lesions, immune regulatory disease, metabolic disease (diabetes, thyroid disease) or malignant tumor, reproductive system diseases such as ovarian cysts, endometriosis, etc.
- •Laboratory tests or Electrocardiogram were significantly abnormal, and judging by the researchers may damage the patient safety or successful completion of the clinical research:
- •Male hemoglobin <120g/L, female hemoglobin <100g/L;
- •Male serum creatinine≥133umol/L, female serum creatinine≥124umol/L; or creatinine clearance rate≤60ml/min;
- •Chronic liver disease and/or abnormal liver function, defined as AST (aspartate aminotransferase) > 1.5 x ULN (Upper Limit Of Normal) and/or ALT (alanine aminotransferase) > 1.5 x ULN and/or total bilirubin > 1.5x ULN;
- •Serious psychiatric patients( Hamilton Depression Scale scores>20).
- •History of drug abuse or alcohol abuse.
- •Allergic to this study drug.
- •Concomitant medication is unable to stop or use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology, parasympathetic inhibitors, muscle relaxants, antidiarrheal, opiates, etc.
- •Do not fill in the electronic log of one week before entering the group (-1 week) completely.
- •Pregnant or lactating women
- •Is participating in clinical trials or have finished it less than 3 months.
- •Other researchers think not suitable for the list.
研究组 & 干预措施
Starch capsule
During the 12- weeks treatment phase of the study, the daily dose of 3 tablets will be taken 30 minutes after breakfast, lunch and supper.
干预措施: Starch Placebo (Drug)
N-acetyl-D-glucosamine
During the 12- weeks treatment phase of the study, the daily dose of 100mg*3 (3 tablets) will be taken 30 minutes after breakfast, lunch and supper.
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
- General symptoms feel grading(one and a half years)
- defecation frequency(one and a half years)
- abdominal distension(one and a half years)
- Defecation urgency(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