clinical trials of n-acetyl glucosamine capsule for ibs-d treatment

Conditions: Irritable Bowel Syndrome

Summary: 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).


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: diarrhea abdominal pain