Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06494683

Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus

Led by Jiangxi University of Traditional Chinese Medicine · Updated on 2025-02-21

200

Participants Needed

2

Research Sites

74 weeks

Total Duration

On this page

Sponsors

J

Jiangxi University of Traditional Chinese Medicine

Lead Sponsor

T

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM).

CONDITIONS

Official Title

Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of type 2 diabetes mellitus with fasting blood glucose �3E�3D 126 mg/dl or 2-hour postprandial blood glucose �3E�3D 200 mg/dL, or HbA1c �3E�3D 6.5%
  • Age between 18 and 80 years old
  • Untreated or currently on regular anti-diabetic medication therapy including oral drugs and insulin
  • Blood glucose not well controlled in the past three months with HbA1c between 6.5% and 10.5%
  • Willing to follow dietary control during the study
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Type 1 diabetes, gestational diabetes, or special types of diabetes
  • History of diabetic acute complications such as ketoacidosis, hyperosmolar coma, or lactic acidosis
  • Pregnant or lactating women, or planning pregnancy
  • Allergy to Pueraria lobata radix
  • Severe dysfunction of heart, liver, or kidney, malignant tumors, or severe mental disorders
  • Expected poor compliance or communication difficulties
  • Currently participating in other clinical trials

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330004

Not Yet Recruiting

2

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China, 330006

Actively Recruiting

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Research Team

X

Xu Zhou, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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