Clinical trial NCT05720442: Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy
Official title: Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diabetic Gastroenteropathy
Keywords: Diabetic Gastroenteropathy
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 70 years at the time of their consent;
2. 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;
3. History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month;
4. Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT);
5. TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome;
6. Signed informed consent.

Exclusion Criteria:

1. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month;
2. Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs;
3. Have a history of or are suffering from severe gastrointestinal disease
4. Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year;
5. Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence;
6. Women who are pregnant, preparing for pregnancy or breastfeeding;
7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies;
8. 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.

Primary outcomes:
measure: Sub-scores of the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
timeFrame: Baseline to Week 4
measure: Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
timeFrame: 0 week, 4 weeks
Secondary outcomes:
measure: Changes from Baseline Fasting Blood Glucose at 4 weeks
timeFrame: 0 week, 4 weeks
measure: Changes from Baseline Body Mass Index at 4 weeks
timeFrame: 0 week, 4 weeks
measure: Change from Baseline TCM Symptom Score at 4 weeks
timeFrame: 0 week, 4 weeks
measure: SF-36 Health Survey Questionnaire
timeFrame: 0 week, 4 weeks
Other outcomes:
measure: Adverse events (AEs)
timeFrame: 0 week, 4 weeks
Locations:
Study officials:
References: