Multicenter Withdrawal 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 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.