Efficacy and safety of tangweian recipe in the treatment of diabetic gastroparesis: a protocol for a non-inferiority, double-blind, active drug, randomized controlled clinical trial.

BACKGROUND

Diabetic Gastroparesis (DGP) is a syndrome characterized by delayed gastric emptying and upper gastrointestinal symptoms. As the incidence of diabetes mellitus continues to increase, so does the incidence of DGP, which severely affects the fasting plasma glucose (FPG) control and quality of life of diabetic patients. Tangweian recipe (TWA) is an effective recipe for treating DGP with spleen and stomach disharmony evidence. Previous clinical trials have provided preliminary verification of the effectiveness of TWA in treating DGP. However, high-quality clinical evidence supporting this treatment is lacking. Therefore, the purpose of this study is to conduct a clinical randomized controlled trial to obtain conclusive evidence regarding the effectiveness of TWA.

METHODS AND ANALYSIS: This study is a randomized, positive, parallel controlled clinical trial in patients with DGP. A total of 72 patients were recruited and randomized using a random number method to receive either TWA combined with mosapride or mosapride alone for a treatment period of 4 weeks.

PRIMARY OUTCOME: The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD).

SECONDARY OUTCOMES: Changes in FPG, weight, body mass index (BMI), gastric emptying rate testing, Wexner constipation scores, traditional chinese medicine (TCM) evidence scores and quality of life (QOL) assessment before and after treatment. In addition, we will also perform a safety analysis.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (NCT05720442) on February 9,2023 ( https://clinicaltrials.gov/study/NCT05720442 ), and the registration center is Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine.