Tangningtongluo Tablet for People With Prediabetes

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing University of Chinese Medicine

Criteria

Inclusion Criteria:

• FPG 5.6mmol/L~6.9mmol/L or OGTT 2H blood glucose 7.8mmol/L~11.0mmol/L or HbA1c 5.7%~6.4%, the above 3 indicators need to meet at least 2 items；

• Age 18 ~ 70 years old (including boundary value);

• Patients who voluntarily signed the informed consent and had conditional follow-up.

Exclusion Criteria:

• Regularly take drugs affecting blood glucose within 1 month before screening, such as hypoglycemic drugs, glucocorticoids, niacin β- Adrenergic agonists, thyroid hormones, contraceptives, diazoxide, diuretics, phenytoin sodium γ- Interferon, etc;

• Combined with various diseases that may significantly shorten life expectancy, such as malignant tumors, severe organ failure and so on;

• Combined with various diseases that may seriously affect the subject's participation in the test, such as psychosis, serious motor system abnormalities, etc;

• Combined ALT or ast > 2.5 times the upper limit of normal value, or serum creatinine > 1.5mg/dl;

• Allergic to the test drug or its components;

• Pregnant or lactating women, or women who have pregnancy plans from the study period to 3 months after the last administration, or men who are unwilling to take a medically recognized effective non drug contraceptive measure.

• Chronic diarrhea caused by inflammatory bowel disease and irritable bowel syndrome;

• The investigator believes that it is inappropriate to be included in this trial.