Using Sanggua tablets to treat mild Type 2 diabetes and impaired glucose tolerance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Sanggua tablets, a Traditional Chinese Medicine formula, in treating patients with impaired glucose tolerance and mild Type 2 diabetes mellitus. The study employs a randomized, double-blind, placebo-controlled design, where participants will receive either the Sanggua tablets or a placebo over a specified period. The trial aims to assess the tablets' ability to lower blood glucose levels and improve lipid profiles, leveraging the synergistic effects of its herbal components. The findings could provide insights into alternative therapies for managing early-stage diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18-70 with impaired glucose tolerance (IGT).
* Or patients aged 18-70 diagnosed with type 2 diabetes mellitus (T2DM) deemed by the clinician not requiring pharmacological intervention.
* And(or) glycated hemoglobin (HbA1c) levels between 5.7% 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 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 been diagnosed with malignant tumors.
* 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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Gang Yuan, Professor — Tongji Hospital
• Study coordinator: Gang Yuan, Professor
• Email: gangyuan@tjh.tjmu.edu.cn
• Phone: 0086-027-13871523102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.