Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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;