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

NCT06494683 | Recruiting DMC

• 1 other identifier: JCUCM-DIET-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Changes from baseline in HbA1c levels

  Baseline and Week 12

Secondary Outcomes (20)

• HbA1c

  Baseline, Week 4 and Week 8

• HbA1c response rate

  Baseline, Week 4, Week 8 and Week 12

• Fasting blood glucose

  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

Study Arms (2)

Pueraria lobata radix group

EXPERIMENTAL

Pueraria lobata radix will be made into granules.

Drug: Pueraria lobata radix

Placebo group

PLACEBO COMPARATOR

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

Interventions

Pueraria lobata radix DRUG

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.

Also known as: Ge Gen

Placebo group; Pueraria lobata radix group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (2)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330004, China

NOT YET RECRUITING

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330006, China

RECRUITING

Related Publications (1)

• Chen J, Wang J, Yuan L, Xue Q, Zhou J, Ye X, Fan Q, Feng R, Li C, Zhang Y, Zhu W, Li Z, Zhou X. Efficacy and safety of Pueraria lobata radix as an adjuvant therapy for type 2 diabetes mellitus: rationale, design and protocol for a randomised controlled trial. BMJ Open. 2025 May 24;15(5):e092050. doi: 10.1136/bmjopen-2024-092050.

  PMID: 40413050 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

plant extract, Puerariae Radix

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xu Zhou, M.D

  Jiangxi University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Zhou, M.D

CONTACT

+8618870050733; zhouxu_ebm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 25, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)