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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Gastroenteropathy
• Intervention / Treatment: Drug: Tangweian Recipe; Drug: Mosapride Citrate

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiaxing Tian; Phone Number: 86+01088002289; Email: tina_yai@126.com
• Study Contact Backup: Name: Yuxin Zhang; Email: yuxin_zhang96@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tangweian Recipe 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.	Drug: Tangweian Recipe; The Tangweian recipe is a combination of several Chinese herbs; Drug: Mosapride Citrate; The mosapride citrate tablets will be administrated.
ACTIVE_COMPARATOR: Mosapride Citrate Group; 1 mosapride citratetablet per time, 3 times a day, take it with meals.	Drug: Mosapride Citrate; The mosapride citrate tablets will be administrated.

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	0 week, 4 weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): January 31, 2025
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic Gastroenteropathy
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Mosapride
• Other Study ID Numbers: SFIMD2022B06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No