Status:
RECRUITING
Efficacy and Safety of Sanggua Tablets in the Treatment of Patients With Impaired Glucose Tolerance and Mild Type 2 Diabetes
Lead Sponsor:
Tongji Hospital
Conditions:
Diabetes Mellitus, Type 2
Impaired Glucose Tolerance
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
Type 2 diabetes mellitus (T2DM) and impaired glucose tolerance (IGT) are growing public health challenges. Early intervention in mild T2DM and IGT is essential to prevent disease progression and sever...
Detailed Description
Type 2 diabetes mellitus (T2DM) and impaired glucose tolerance (IGT) are significant public health concerns, with rising prevalence rates globally. Treating mild T2DM and IGT is crucial to prevent dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06964620
Start Date
May 22 2025
End Date
December 25 2027
Last Update
May 20 2025
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030