Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy
Diabetic Gastroenteropathy
About this trial
This is an interventional treatment trial for Diabetic Gastroenteropathy focused on measuring Diabetic Gastroenteropathy
Eligibility Criteria
Inclusion Criteria: Aged 18 to 70 years at the time of their consent; Those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer; History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month; Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT); TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome; Signed informed consent. Exclusion Criteria: Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month; Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs; Have a history of or are suffering from severe gastrointestinal disease Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year; Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence; Women who are pregnant, preparing for pregnancy or breastfeeding; Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies; According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tangweian Recipe Group
Mosapride Citrate Group
Tangweian formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. 1 mosapride citratetablet per time, 3 times a day, take it with meals.
1 mosapride citratetablet per time, 3 times a day, take it with meals.