Diabetic gastrointestinal neuropathy
Conditions
Interventions
Jinlida Granules Intervention Group:Oral supplementation with Jinlida Granules 9g,tid
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed T2DM according to the 1999 World Health Organization criteria, age: 30-80 years old 2. Glycosylated hemoglobin (HbA1c) =6.5% and =9%; 3. Meet the diagnostic criteria for chronic functional constipation, with a disease duration of =6 months; 4. No history of laxative use in the last 1 month; 5. Patients voluntarily signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with serious liver and kidney function damage and serious primary diseases of cardiovascular and hematopoietic systems; malignant tumors, metabolic diseases such as hyperthyroidism and hypothyroidism, and psychiatric diseases; 2.Patients with complications such as diabetic ketoacidosis and acute pancreatitis within 1 month; 3. Autoimmune dysfunction, severe anemia and neutropenia; 4. Patients who have used drugs that may affect the evaluation of clinical results in the last 1 month, such as antibiotics, laxatives, microecological preparations, proprietary Chinese medicines and tonics; 5.Patients with organic lesions of the gastrointestinal tract, such as gastrointestinal ulcers, colon polyps, intestinal tumors, inflammatory bowel disease, etc; 6. History of intestinal resection or other gastrointestinal surgery (e.g. cholecystectomy) within the past 1 year; 7. Symptoms of constipation already present before diagnosis of diabetes mellitus; 8. Concurrent participation in other studies; 9. Patients with organic constipation or pharmacologic constipation; 10. Allergy or the presence of an allergic reaction to the drugs in this test; 11. Women who are pregnant, preparing for pregnancy or breastfeeding; 12. Other pathologies or conditions that, in the judgment of the investigator, have the effect of reducing the likelihood of enrollment or complicating enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total CSBM response at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Constipation Symptom Score;Fecal Trait Score;Colonic transit; | — |
Countries
China
Contacts
Public ContactQin Guijun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed