drugset / Trial / NCT05126251

Tangningtongluo Tablet for People With Prediabetes

NCT05126251 ↗

Phase 2 Unknown 240 enrolled Beijing University of Chinese Medicine
RandomizedParallel-groupTriple-blindTreatment

Summary

Prediabetes is an intermediate transition to hyperglycemia between normal blood glucose and diabetes, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT)and the presence of a combination of the two. At present, the prediabetes population in China is very large. Timely detection of this sub-health population and effective intervention are the key to prevent or delay diabetes and related complications. Basic research showed that Tangningtongluo had a good hypoglycemic effect on db/db diabetic mice and STZ induced diabetic rats, and could alleviate pancreatic islet destruction and insulin resistance to some extent. In this study, the therapeutic effects of Tangningtongluo pian provided by Guizhou bailing Enterprise Group Pharmaceutical Co., Ltd on patients with prediabetes was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Tangningtongluo pian in the treatment of prediabetes . In the design of this trial, the therapeutic effects and safety of Tangningtongluo pian in the treatment of prediabetes were evaluated with Tangningtongluo pian in the treatment group and placebo in the control group.

Timeline

Start
2021-12-13
Primary completion
2022-12-31
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tangning Tongluo Unknown 1.6 g Oral

Indications