Actively Recruiting
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
Eligibility Criteria
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
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
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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