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

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 severe complications. Traditional Chinese Medicine (TCM) provides a potential therapeutic approach. Sanggua tablets, a TCM formula composed of mulberry leaf, bitter melon, kudzu root, Chinese yam, and cassia seed, embody TCM principles of clearing heat, generating body fluids, tonifying the spleen and stomach, and nourishing the lungs and kidneys. Modern studies show that Sanggua tablets effectively lower blood glucose and improve lipid profiles through components like mulberry polysaccharides and bitter melon saponins. These findings suggest their potential as an alternative or complementary therapy for mild T2DM and IGT. This study will conduct a randomized, double-blind, placebo-controlled, parallel-group clinical trial among patients with IGT and mild T2DM. Participants will receive a 16-week intervention with Sanggua tablets. The primary outcome is glycated hemoglobin (HbA1c), with secondary outcomes such as fasting blood glucose (FBG), fasting insulin (FINS), HOMA-IR, lipid profiles and so on. Safety will be closely monitored. Additionally, fecal samples will be collected for 16S rDNA sequencing to explore the role of gut microbiota in the therapeutic effects of Sanggua tablets. This study aims to provide evidence for the clinical application and development of Sanggua tablets as a novel TCM therapy.

Eligibility

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.

Conditions3

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