Using Pueraria Lobata Radix to help manage Type 2 Diabetes

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

This study is testing whether a plant extract called Pueraria lobata can help adults with type 2 diabetes better control their blood sugar levels when used alongside their current diabetes medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangxi University of Traditional Chinese Medicine (Academic / other)
• Locations: 2 sites (Nanchang, Jiangxi and 1 other locations)
• Trial ID: NCT06494683 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Pueraria lobata radix (PLR) as an adjunctive treatment for type 2 diabetes mellitus (T2DM). It is a randomized, double-blind, placebo-controlled trial that aims to provide evidence for the hypoglycemic effects of PLR, which has shown promise in animal studies. Participants will include adults aged 18 to 80 with poorly controlled blood glucose levels, and they may be receiving other anti-diabetic medications. The study will assess how PLR can complement existing treatments to improve glycemic control.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with type 2 diabetes who have not achieved effective blood glucose control.

Not a fit: Patients with type 1 diabetes, gestational diabetes, or those with a history of severe diabetic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients struggling to manage their type 2 diabetes.

How similar studies have performed: While animal studies have shown positive results with PLR, this approach is novel in the context of human clinical trials.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi and 1 other locations

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Xu Zhou, M.D — Jiangxi University of Traditional Chinese Medicine
• Study coordinator: Xu Zhou, M.D

Conditions Type 2 Diabetes Mellitus; Pueraria lobata radix; Ge Gen; Type 2 diabetes mellitus; Randomized controlled trial