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

NCT ID: NCT05720442

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-01-01

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.

Conditions

Diabetic Gastroenteropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tangweian Recipe Group

1. Tangweian formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals.

2. 1 mosapride citratetablet per time, 3 times a day, take it with meals.

Group Type: EXPERIMENTAL

Tangweian Recipe

Intervention Type: DRUG

The Tangweian recipe is a combination of several Chinese herbs

Mosapride Citrate

Intervention Type: DRUG

The mosapride citrate tablets will be administrated.

Mosapride Citrate Group

1 mosapride citratetablet per time, 3 times a day, take it with meals.

Group Type: ACTIVE_COMPARATOR

Mosapride Citrate

Intervention Type: DRUG

The mosapride citrate tablets will be administrated.

Interventions

Tangweian Recipe

The Tangweian recipe is a combination of several Chinese herbs

Intervention Type: DRUG

Mosapride Citrate

The mosapride citrate tablets will be administrated.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jiaxing Tian

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jiaxing Tian

Role: CONTACT

tina_yai@126.com

86+01088002289

Yuxin Zhang

Role: CONTACT

yuxin_zhang96@163.com

Other Identifiers

SFIMD2022B06

Identifier Type: -

Identifier Source: org_study_id