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Efficacy and Safety of Hebenrun in Patients With Type 2 Diabetes

NCT07768280 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-08-17

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of Hebenrun (a functional food based on natural grain bran) combined with metformin in patients with type 2 diabetes mellitus (T2DM). The study hypothesis is that Hebenrun combined with metformin will achieve a higher complete discontinuation rate of oral hypoglycemic drugs compared to metformin alone. A total of 110 T2DM patients will be randomly assigned (1:1) to the study group (metformin + Hebenrun) or the control group (metformin alone) and followed for 48 weeks. The primary outcome is the complete discontinuation rate of oral hypoglycemic drugs at the end of follow-up.

Conditions

Interventions

DRUG

Metformin

Metformin tablet, 0.5 g, twice daily, taken before meals; dose may be adjusted ±500 mg/d based on glycemic control; treatment duration: 48 weeks.

DIETARY_SUPPLEMENT

Hebenrun

Hebenrun, a functional food based on natural grain bran, taken as one sachet twice daily (morning and evening) before meals, for 48 weeks.

Sponsors & Collaborators

  • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    collaborator OTHER

  • Jiangxi University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Li · The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-02-29
Completion
2028-03-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT07768280 on ClinicalTrials.gov