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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangweian Recipe Group | Experimental |
|
|
| Mosapride Citrate Group | Active Comparator | 1 mosapride citratetablet per time, 3 times a day, take it with meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangweian Recipe | Drug | The Tangweian recipe is a combination of several Chinese herbs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 4 |
| Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) | 0 week, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline Fasting Blood Glucose at 4 weeks | 0 week, 4 weeks | |
| Changes from Baseline Body Mass Index at 4 weeks | 0 week, 4 weeks | |
| Change from Baseline TCM Symptom Score at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | 0 week, 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxing Tian | Contact | 86+01088002289 | tina_yai@126.com | |
| Yuxin Zhang | Contact | yuxin_zhang96@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41310560 | Derived | Zhang YX, Yin RY, Zhang YJ, Ji HY, Ma JZ, Zhang C, Zhang LL, Wu XA, Li M, Tian JX. Efficacy and safety of tangweian recipe in the treatment of diabetic gastroparesis: a protocol for a non-inferiority, double-blind, active drug, randomized controlled clinical trial. BMC Complement Med Ther. 2025 Nov 27;26(1):7. doi: 10.1186/s12906-025-05104-5. |
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| Mosapride Citrate | Drug | The mosapride citrate tablets will be administrated. |
|
| 0 week, 4 weeks |
| SF-36 Health Survey Questionnaire | 0 week, 4 weeks |
| ID | Term |
|---|---|
| C062720 | mosapride |
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