This study is a randomized, positive drug parallel-controlled clinical trial in participants with diabetic gastroenteropathy. A total of 60 participants will be recruited for the study, all of whom are diagnosed as diabetes mellitus combined with gastroenteropathy. The subjects will be divided randomly into two groups and treated with either Tangweian Recipe+mosapride citrate tablets or mosapride citrate tablets for four weeks. The primary outcome will be the change in gastroparesis symptom severity, as measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Daily diary Index-Daily Diary (ANMS GCSI-DD). And participants will be seen for a clinic evaluation at weeks 0 and 4, during which symptom scores, adverse events and treatment compliance will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Tangweian recipe is a combination of several Chinese herbs
The mosapride citrate tablets will be administrated.
Sub-scores of the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Change from Baseline at weeks 0 through 4 as measured by patient's daily diary entries during participation in the study.
Time frame: Baseline to Week 4
Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
Time frame: 0 week, 4 weeks
Changes from Baseline Fasting Blood Glucose at 4 weeks
Time frame: 0 week, 4 weeks
Changes from Baseline Body Mass Index at 4 weeks
Time frame: 0 week, 4 weeks
Change from Baseline TCM Symptom Score at 4 weeks
Time frame: 0 week, 4 weeks
SF-36 Health Survey Questionnaire
Time frame: 0 week, 4 weeks
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