An interventional study of Pueraria lobata radix in Type 2 Diabetes Mellitus, sponsored by Jiangxi University of Traditional Chinese Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Jiangxi University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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).
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Jiangxi University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pueraria lobata radix will be made into granules.
Drug: Pueraria lobata radix
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.
Also known as: Ge Gen
HbA1c
Changes from baseline in HbA1c levels
Time frame: Baseline and Week 12
HbA1c
Changes from baseline in HbA1c levels
Time frame: Baseline, Week 4 and Week 8
HbA1c response rate
Proportion of patients with HbA1c \< 7.0%
Time frame: Baseline, Week 4, Week 8 and Week 12
Fasting blood glucose
Changes from baseline in fasting blood glucose levels
Time frame: Baseline, Week 4, Week 8 and Week 12
Two-hour postprandial glucose
Changes from baseline in two-hour postprandial glucose levels
Time frame: Baseline, Week 4, Week 8 and Week 12
Fasting C-peptide
Changes from baseline in fasting C-peptide levels
Time frame: Baseline, Week 4, Week 8 and Week 12
Body mass index
Changes from baseline in body mass index
Time frame: Baseline, Week 4, Week 8 and Week 12
Total cholesterol
Changes from baseline in total cholesterol levels
Time frame: Baseline and Week 12
Triglycerides
Changes from baseline in triglycerides levels
Time frame: Baseline and Week 12
High-density lipoprotein cholesterol
Changes from baseline in high-density lipoprotein cholesterol levels
Time frame: Baseline and Week 12
Low-density lipoprotein cholesterol
Changes from baseline in low-density lipoprotein cholesterol levels
Time frame: Baseline and Week 12
Non-high-density lipoprotein cholesterol
Changes from baseline in non-high-density lipoprotein cholesterol levels
Time frame: Baseline and Week 12
Systolic blood pressure
Changes from baseline in systolic blood pressure
Time frame: Baseline, Week 4, Week 8 and Week 12
Diastolic blood pressure
Changes from baseline in diastolic blood pressure
Time frame: 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".
Time frame: 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).
Time frame: Baseline, Week 4, Week 8 and Week 12
Hypoglycemic drug dose
Changes from baseline in hypoglycemic drug dose
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 4, Week 8 and Week 12
Incidence of individual adverse events
The main concern is hypoglycemia and gastrointestinal reactions.
Time frame: Baseline, Week 4, Week 8 and Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 17 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangxi University of Traditional Chinese Medicine