Status:
RECRUITING
Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus
Lead Sponsor:
Jiangxi University of Traditional Chinese Medicine
Collaborating Sponsors:
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
The First Affiliated Hospital of Nanchang University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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. The...
Detailed Description
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. The...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus according to the International Diabetes Guidelines: fasting blood glucose (FBG) ≥ 126 mg/dl (7.0 mmol/l) or 2-hour postprandial blood glucose ≥ 200 mg/dL (11.1 mmol/l), or HbA1c ≥ 6.5% (48 mmol/mol).
- Age between 18 and 80 years old.
- Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.
- Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.
- Willingness to comply with dietary control requirements during the study.
- Voluntary participation and signing of informed consent form.
Exclusion
- Type 1 diabetes, gestational diabetes, and special types of diabetes.
- History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.
- Pregnant or lactating women, or women planning pregnancy.
- Allergy history to Pueraria lobata radix.
- Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders.
- Anticipated poor compliance or language communication impairments.
- Currently participating in other clinical trials.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06494683
Start Date
July 25 2024
End Date
December 30 2025
Last Update
February 21 2025
Active Locations (2)
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1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330004
2
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330006