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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
720
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGAbdominal Pain Intensity
As measured by numerical rating scale
Time frame: one and a half years
Stool Consistency
As measured by Bristol ' s scale
Time frame: one and a half years
General symptoms feel grading
As measure by patient reported outcome measures
Time frame: one and a half years
defecation frequency
As measure by patient reported outcome measures
Time frame: one and a half years
abdominal distension
As measure by patient reported outcome measures
Time frame: one and a half years
Defecation urgency
As measure by patient reported outcome measures
Time frame: one and a half years
life quality parameters
As measure by healthy survey, SF-36
Time frame: one and a half years
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