Efficacy and Safety of Sanggua Tablets in the Treatment of Patients With Impaired Glucose Tolerance and Mild Type 2 Diabetes

Launched by TONGJI HOSPITAL · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of Sanggua tablets, a traditional Chinese medicine, in treating patients with impaired glucose tolerance (IGT) and mild type 2 diabetes (T2DM). The goal is to see if these tablets can help lower blood sugar levels and improve overall health in patients who are not yet on medication for their diabetes. Participants will take Sanggua tablets for 16 weeks, and researchers will closely monitor changes in their blood sugar and other health markers.

To be eligible for the trial, participants should be between 18 and 70 years old, have IGT or mild T2DM with specific blood sugar levels, and must be willing to follow the study rules. However, people with certain health conditions or those taking specific medications, such as insulin or other diabetes drugs, cannot join. If you participate, you’ll need to sign a consent form and may also provide a stool sample to help researchers understand how gut health relates to the tablets' effects. This study aims to gather important information that could support the use of Sanggua tablets as a new treatment option for managing diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18-70 with impaired glucose tolerance (IGT).
• • Patients aged 18-70 diagnosed with type 2 diabetes mellitus (T2DM) deemed by the clinician not requiring pharmacological intervention.
• • Glycated hemoglobin (HbA1c) levels between 5.6% and 7.5%.
• • Voluntarily sign an informed consent form before the commencement of trial-related activities, understand the procedures and methods of the trial, and are willing and able to strictly adhere to the clinical trial protocol to complete the study.
• Exclusion Criteria:
• • Type 1 diabetes mellitus.
• • Known allergies to Sang Gua tablets or any of its components.
• • Use of hypoglycemic or lipid-lowering drugs within the last three months.
• • Presence of severe primary or secondary respiratory, cardiovascular, hepatic, or renal diseases, rheumatic connective tissue diseases, or hematological disorders.
• • Uncontrolled or unstable conditions exacerbated by infections, severe electrolyte imbalances, or other factors.
• • Patients with primary or secondary kidney diseases, hypertension, heart failure, acidosis, or urinary tract infections causing increased urinary protein, excepted.
• • Patients with psychiatric disorders.
• • Pregnant or planning to become pregnant women, or nursing mothers.
• • Patients requiring long-term steroid therapy.
• • Patients with poorly controlled hypertension or secondary hypertension.
• • Patients who have participated in other clinical trials within the past three months.
• • Patients deemed by the investigator as unsuitable for this clinical trial due to potential interference with trial results, impediments to full participation in the study, medical history, disease evidence, abnormal treatments, or laboratory values, or any other condition considered by the investigator to pose potential risks for participation in the study.