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

Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Pueraria lobata radix

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. 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).

T2DM is the most prevalent chronic metabolic disease. It has been noted in clinical practice that the limitations of conventional treatment methods, such as secondary failure and adverse reactions, continue to pose challenges for patients in managing their blood glucose levels, preventing them from achieving optimal glycemic control goals. Therefore, it is essential to search for more effective and safe complementary medications.

PLR (Chinese name: Ge Gen) is the dried root of the leguminous plant kudzu (Pueraria lobata (Willd.) Ohwi). In China and other East Asian countries, PLR has been widely used to treat metabolic diseases, including T2DM. The chemical components of PLR include isoflavones, triterpenes, saponins, polysaccharides, coumarin compounds, and alkaloids, with isoflavones being the primary active ingredients of PLR. Multiple animal studies have shown that the main active components in isoflavones, such as puerarin, daidzein, and genistein, effectively increase serum insulin concentrations, lower blood glucose levels, and improve insulin resistance in diabetic mice. Puerarin injection has been widely used in China for the treatment of diabetes and its complications.

PLR is classified as a medicinal and edible herb according to Chinese regulations, demonstrating good safety, with no reports of adverse reactions from long-term consumption in practice. However, there is currently a lack of randomized controlled trial evidence on the use of PLR for assisting in glycemic management. Therefore, this study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of daily PLR treatment for adjunctive management of T2DM.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu Zhou, M.D; Phone Number: +8618870050733; Email: zhouxu_ebm@hotmail.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330004
      • Not yet recruiting
      • The First Affiliated Hospital of NanChang University
      • Contact: Jianrong Chen
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
      • Contact: Zhengfeng Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. Age between 18 and 80 years old.
3. Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.
4. Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.
5. Willingness to comply with dietary control requirements during the study.
6. Voluntary participation and signing of informed consent form.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, and special types of diabetes.
2. History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.
3. Pregnant or lactating women, or women planning pregnancy.
4. Allergy history to Pueraria lobata radix.
5. Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders.
6. Anticipated poor compliance or language communication impairments.
7. Currently participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pueraria lobata radix group; Pueraria lobata radix will be made into granules.	Drug: Pueraria lobata radix; The dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb.; Other Names: Ge Gen
Placebo Comparator: Placebo group; The dosage form, specifications and packaging of the placebo will be no different from those of Pueraria lobata radix granules, and the smell and taste will be basically the same.	Drug: Pueraria lobata radix; The dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb.; Other Names: Ge Gen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes from baseline in HbA1c levels	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes from baseline in HbA1c levels	Baseline, Week 4 and Week 8
HbA1c response rate	Proportion of patients with HbA1c < 7.0%	Baseline, Week 4, Week 8 and Week 12
Fasting blood glucose	Changes from baseline in fasting blood glucose levels	Baseline, Week 4, Week 8 and Week 12
Two-hour postprandial glucose	Changes from baseline in two-hour postprandial glucose levels	Baseline, Week 4, Week 8 and Week 12
Fasting C-peptide	Changes from baseline in fasting C-peptide levels	Baseline, Week 4, Week 8 and Week 12
Body mass index	Changes from baseline in body mass index	Baseline, Week 4, Week 8 and Week 12
Total cholesterol	Changes from baseline in total cholesterol levels	Baseline and Week 12
Triglycerides	Changes from baseline in triglycerides levels	Baseline and Week 12
High-density lipoprotein cholesterol	Changes from baseline in high-density lipoprotein cholesterol levels	Baseline and Week 12
Low-density lipoprotein cholesterol	Changes from baseline in low-density lipoprotein cholesterol levels	Baseline and Week 12
Non-high-density lipoprotein cholesterol	Changes from baseline in non-high-density lipoprotein cholesterol levels	Baseline and Week 12
Systolic blood pressure	Changes from baseline in systolic blood pressure	Baseline, Week 4, Week 8 and Week 12
Diastolic blood pressure	Changes from baseline in diastolic blood pressure	Baseline, Week 4, Week 8 and Week 12
Severity of diabetes symptoms	Severity of diabetes symptoms will be scored using the Diabetes Symptom Grading Scale in the "Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicines".	Baseline, Week 4, Week 8 and Week 12
Diabetes Specific Quality of Life questionnaire scores	Quality of life will be measured using the Diabetes Specific Quality of Life questionnaire (DSQL).	Baseline, Week 4, Week 8 and Week 12
Hypoglycemic drug dose	Changes from baseline in hypoglycemic drug dose	Baseline, Week 4, Week 8 and Week 12
Incidence of any adverse events	An adverse event is defined as any medically induced harm, excluding those due to nature progression of diabetes mellitus.	Baseline, Week 4, Week 8 and Week 12
Incidence of severe adverse events	Severe adverse events include adverse events that require hospitalization, induce prolonged hospitalization, disability, or impacts on work capacity, are life-threatening, or cause death.	Baseline, Week 4, Week 8 and Week 12
Incidence of treatment-related adverse events	The causality of treatment and adverse events will be assessed by the Clinical Event Committee.	Baseline, Week 4, Week 8 and Week 12
Incidence of individual adverse events	The main concern is hypoglycemia and gastrointestinal reactions.	Baseline, Week 4, Week 8 and Week 12

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine
• Collaborators: The First Affiliated Hospital of Nanchang University; The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xu Zhou, M.D, Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Type 2 diabetes mellitus; Pueraria lobata radix; Ge Gen
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: JCUCM-DIET-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No