Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- HbA1c
Study Overview
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. 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).
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Pueraria lobata radix group
Pueraria lobata radix will be made into granules.
Intervention: Pueraria lobata radix (Drug)
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.
Intervention: Pueraria lobata radix (Drug)
Outcomes
Primary Outcomes
HbA1c
Time Frame: Baseline and Week 12
Changes from baseline in HbA1c levels
Secondary Outcomes
- HbA1c response rate(Baseline, Week 4, Week 8 and Week 12)
- Body mass index(Baseline, Week 4, Week 8 and Week 12)
- Total cholesterol(Baseline and Week 12)
- HbA1c(Baseline, Week 4 and Week 8)
- Low-density lipoprotein cholesterol(Baseline and Week 12)
- Severity of diabetes symptoms(Baseline, Week 4, Week 8 and Week 12)
- Diabetes Specific Quality of Life questionnaire scores(Baseline, Week 4, Week 8 and Week 12)
- Incidence of any adverse events(Baseline, Week 4, Week 8 and Week 12)
- Incidence of treatment-related adverse events(Baseline, Week 4, Week 8 and Week 12)
- Two-hour postprandial glucose(Baseline, Week 4, Week 8 and Week 12)
- Fasting C-peptide(Baseline, Week 4, Week 8 and Week 12)
- Triglycerides(Baseline and Week 12)
- High-density lipoprotein cholesterol(Baseline and Week 12)
- Systolic blood pressure(Baseline, Week 4, Week 8 and Week 12)
- Diastolic blood pressure(Baseline, Week 4, Week 8 and Week 12)
- Hypoglycemic drug dose(Baseline, Week 4, Week 8 and Week 12)
- Fasting blood glucose(Baseline, Week 4, Week 8 and Week 12)
- Non-high-density lipoprotein cholesterol(Baseline and Week 12)
- Incidence of individual adverse events(Baseline, Week 4, Week 8 and Week 12)
- Incidence of severe adverse events(Baseline, Week 4, Week 8 and Week 12)
Investigators
Xu Zhou
Professor
Jiangxi University of Traditional Chinese Medicine