Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
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).