Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

Conditions
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Diabetic Gastroenteropathy

Intervention / Treatment
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* Drug: Tangweian Recipe
* Drug: Mosapride Citrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tangweian Recipe Group<br>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. | Drug: Tangweian Recipe<br>* The Tangweian recipe is a combination of several Chinese herbs<br>Drug: Mosapride Citrate<br>* The mosapride citrate tablets will be administrated.<br>|
| Active Comparator: Mosapride Citrate Group<br>1 mosapride citratetablet per time, 3 times a day, take it with meals. | Drug: Mosapride Citrate<br>* The mosapride citrate tablets will be administrated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 0 week, 4 weeks | 
| SF-36 Health Survey Questionnaire |  | 0 week, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Gastroenteropathy