MedTrace Logo

Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk

NCT07775664 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-20

No results posted yet for this study

Summary

This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional Chinese medicine criteria for Qi-Yin deficiency syndrome.

A total of 90 participants are randomly assigned in a 1:1 ratio to receive either Huangqi Gegen Decoction granules or matching placebo granules, in addition to their usual guideline-based treatment, for 12 weeks. Participants and investigators are blinded to treatment assignment.

The main outcome is flow-mediated dilation (FMD), a noninvasive measure of how well blood vessels dilate. The study also evaluates blood glucose control, blood markers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety.

The investigators hypothesize that Huangqi Gegen Decoction, when added to conventional treatment, will improve endothelial function compared with placebo.

Conditions

Interventions

DRUG

Huangqi Gegen Decoction Granules

Huangqi Gegen Decoction granules consist of Huangqi 30 g and Gegen 15 g per daily prescription. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The granules are manufactured by Jiangyin Tianjiang Pharmaceutical Co., Ltd.

DRUG

Placebo Granules

Matching placebo granules mainly consist of maltodextrin. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The placebo is matched to Huangqi Gegen Decoction granules in appearance, packaging, dosage, and administration.

OTHER

Conventional Treatment

Participants continue their stable pre-study conventional treatment regimen for diabetes and cardiovascular risk management throughout the 12-week study. Treatment is continued according to the participant's pre-study regimen and relevant Chinese clinical guidelines, with clinically necessary adjustments permitted for safety.

Sponsors & Collaborators

  • Putuo Hospital, Shanghai University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-04
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775664 on ClinicalTrials.gov