Recruiting

Sanggua Tablets for Impaired Glucose Tolerance and Mild Type 2 Diabetes

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What is being tested

Sanggua tablets

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+5

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorTongji Hospital
Study ContactGang Yuan, Professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 22, 2025

Actual date on which the first participant was enrolled.

This study focuses on testing the effectiveness and safety of Sanggua tablets, a traditional Chinese medicine, for people with mildly impaired blood sugar levels, known as mild Type 2 Diabetes and impaired glucose tolerance. These conditions can lead to serious health issues like heart disease if not managed well. Sanggua tablets combine several natural ingredients, such as mulberry leaf and bitter melon, believed to help lower blood sugar and improve cholesterol levels. This research aims to see if these tablets could be a helpful addition or alternative to current treatments, providing more options for managing these conditions. Participants in this study will be randomly chosen to receive either Sanggua tablets or a placebo, alongside their usual treatment, over a 16-week period. The study will closely monitor blood sugar levels and other health indicators, such as cholesterol levels and insulin resistance, to measure the tablets' effectiveness. Safety is also a priority, with participants undergoing regular health checks. Additionally, the study will explore how these tablets might influence gut bacteria by analyzing stool samples. This research involves several visits for tests and assessments to ensure comprehensive data collection on the tablets' impact.

Official TitleEfficacy and Safety of Sanggua Tablets in the Treatment of Patients With Impaired Glucose Tolerance and Mild Type 2 Diabetes
NCT06964620
Principal SponsorTongji Hospital
Study ContactGang Yuan, Professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesGlucose IntoleranceGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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.
12 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Conventional treatment plus Sanggua tablets (0.75 g per tablet, twice daily, bid) for 16 weeks

Group II

Placebo
Conventional treatment plus placebo (0.75 g per tablet, twice daily, bid) for 16 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tongji Hospital

Wuhan, ChinaOpen Tongji Hospital in Google Maps
Recruiting
One Study Center
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