MedTrace Logo

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

NCT05720442 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

DRUG

Tangweian Recipe

The Tangweian recipe is a combination of several Chinese herbs

DRUG

Mosapride Citrate

The mosapride citrate tablets will be administrated.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-01-31
Completion
2026-01-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720442 on ClinicalTrials.gov