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NCT05126251

Tangningtongluo Tablet for People With Prediabetes

Efficacy and Safety of Tangningtongluo Tablet in People With Prediabetes : a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Beijing University of Chinese Medicine·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Prediabetes
Drug/Device/Intervention
Tangningtongluo tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Beijing University of Chinese Medicine
Location
Xiamen, China
Timeline & enrollment
Phase
Phase 2
Start date
Dec 13, 2021
End date
Jun 30, 2023
Enrollment
240 participants
Primary outcome

Insulin sensitivity index,Pancreatic β-cell function indicators,HbA1c,Metabolic index,Diabetes incidence rate,The rate of blood glucose reversed to normal,Changes in the proportion of subjects diagnosed with fatty liver from baseline,Vascular endothelial function indexes: PAI-1,Vascular endothelial function indexes: NO,Vascular endothelial function indexes: ET-1,Inflammatory factor index: TNF-α,Inflammatory factor index: IL-6,Inflammatory factor index: IL-2,Inflammatory factor index: IL-1β,Inflammatory factor index: adiponectin,Inflammatory factor index: hsCRP,Inflammatory factor index: FGF-21,Urinary albumin creatinine ratio (UACR),Incidence of diabetic retinopathy,Carotid artery intima-media thickness,The scores of prediabetes symptom questionnaire,The scores of short form health survey (SF-36)

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.

ICD-10 classifications
Diabetes mellitusDiabetes mellitus in pregnancy: Pre-existing diabetes mellitus, unspecifiedOther specified diabetes mellitusDiabetes mellitus in pregnancy: Pre-existing diabetes mellitus, non-insulin-dependentDiabetes mellitus in pregnancy: Pre-existing diabetes mellitus, insulin-dependent
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05126251
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05126251 through Pure Global AI's free database. This Phase 2 trial is sponsored by Beijing University of Chinese Medicine and is currently Recruiting. The study focuses on Prediabetes. Target enrollment is 240 participants.

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