Using Sanggua tablets to treat mild Type 2 diabetes and impaired glucose tolerance
Efficacy and Safety of Sanggua Tablets in the Treatment of Patients With Impaired Glucose Tolerance and Mild Type 2 Diabetes
This study is testing if Sanggua tablets, a Traditional Chinese Medicine, can help people with mild Type 2 diabetes and high blood sugar levels feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06964620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with impaired glucose tolerance or mild Type 2 diabetes who do not require pharmacological intervention.
Not a fit: Patients with Type 1 diabetes or those with severe underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel alternative or complementary approach for managing mild Type 2 diabetes and impaired glucose tolerance.
How similar studies have performed: While the use of Traditional Chinese Medicine in diabetes management is gaining interest, this specific approach with Sanggua tablets is relatively novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.