Efficacy and Safety of Pueraria Lobata Radix as an Adjuvant Treatment for Type 2 Diabetes Mellitus
NCT Number: NCT06494683
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Pueraria lobata radix
Sponsor: Jiangxi University of Traditional Chinese Medicine
Collaborators: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine|The First Affiliated Hospital of Nanchang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-30
Locations: The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330004, China|The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi, 330006, China

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).

Primary Outcome Measures: HbA1c, Changes from baseline in HbA1c levels, Baseline and Week 12
Secondary Outcome Measures: 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