Type 2 Diabetes MellitusNCT06494683
Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus
A study testing Pueraria lobata radix in people with Type 2 Diabetes Mellitus, run by Jiangxi University of Traditional Chinese Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pueraria lobata radix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jul 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330004
Jianrong Chen
- Recruiting
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330006
Zhengfeng Li
About this study
Official title: Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial
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).
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pueraria lobata radix
- Keywords
- Pueraria lobata radix, Ge Gen, Type 2 diabetes mellitus, Randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pueraria lobata radixDrug
Also called Ge Gen
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.
| Study group | Role | What they receive |
|---|---|---|
| Pueraria lobata radix group | Experimental | Pueraria lobata radix will be made into granules. Receives: 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. Receives: Drug: Pueraria lobata radix |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Changes from baseline in HbA1c levels
Measured: Baseline and Week 12
Secondary outcomes (20)
HbA1c
Changes from baseline in HbA1c levels
Measured: Baseline, Week 4 and Week 8
HbA1c response rate
Proportion of patients with HbA1c < 7.0%
Measured: Baseline, Week 4, Week 8 and Week 12
Fasting blood glucose
Changes from baseline in fasting blood glucose levels
Measured: Baseline, Week 4, Week 8 and Week 12
Two-hour postprandial glucose
Changes from baseline in two-hour postprandial glucose levels
Measured: Baseline, Week 4, Week 8 and Week 12
Fasting C-peptide
Changes from baseline in fasting C-peptide levels
Measured: Baseline, Week 4, Week 8 and Week 12
Body mass index
Changes from baseline in body mass index
Measured: Baseline, Week 4, Week 8 and Week 12
Total cholesterol
Changes from baseline in total cholesterol levels
Measured: Baseline and Week 12
Triglycerides
Changes from baseline in triglycerides levels
Measured: Baseline and Week 12
High-density lipoprotein cholesterol
Changes from baseline in high-density lipoprotein cholesterol levels
Measured: Baseline and Week 12
Low-density lipoprotein cholesterol
Changes from baseline in low-density lipoprotein cholesterol levels
Measured: Baseline and Week 12
Non-high-density lipoprotein cholesterol
Changes from baseline in non-high-density lipoprotein cholesterol levels
Measured: Baseline and Week 12
Systolic blood pressure
Changes from baseline in systolic blood pressure
Measured: Baseline, Week 4, Week 8 and Week 12
Diastolic blood pressure
Changes from baseline in diastolic blood pressure
Measured: 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".
Measured: 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).
Measured: Baseline, Week 4, Week 8 and Week 12
Hypoglycemic drug dose
Changes from baseline in hypoglycemic drug dose
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8 and Week 12
Incidence of individual adverse events
The main concern is hypoglycemia and gastrointestinal reactions.
Measured: Baseline, Week 4, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start25 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
- Investigators
- Xu Zhou, M.D, Principal investigator, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494683
- Sponsor's protocol ID
- JCUCM-DIET-01
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40413050
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06494683
- Acronym / sponsor ID
- JCUCM-DIET-01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Pueraria lobata radix, Ge Gen, Type 2 diabetes mellitus, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pueraria lobata radix group | Experimental | Drug: Pueraria lobata radixPueraria lobata radix will be made into granules. |
| Placebo group | Placebo comparator | Drug: Pueraria lobata radixThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pueraria lobata radixAlso: Ge GenThe dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb. | Drug | Placebo group, Pueraria lobata radix group |
Primary outcome
HbA1c
Time frame: Baseline and Week 12
Changes from baseline in HbA1c levels
20 secondary outcomes
HbA1c
Time frame: Baseline, Week 4 and Week 8
HbA1c response rate
Time frame: Baseline, Week 4, Week 8 and Week 12
Fasting blood glucose
Time frame: Baseline, Week 4, Week 8 and Week 12
Two-hour postprandial glucose
Time frame: Baseline, Week 4, Week 8 and Week 12
Fasting C-peptide
Time frame: Baseline, Week 4, Week 8 and Week 12
Body mass index
Time frame: Baseline, Week 4, Week 8 and Week 12
Total cholesterol
Time frame: Baseline and Week 12
Triglycerides
Time frame: Baseline and Week 12
High-density lipoprotein cholesterol
Time frame: Baseline and Week 12
Low-density lipoprotein cholesterol
Time frame: Baseline and Week 12
Non-high-density lipoprotein cholesterol
Time frame: Baseline and Week 12
Systolic blood pressure
Time frame: Baseline, Week 4, Week 8 and Week 12
Diastolic blood pressure
Time frame: Baseline, Week 4, Week 8 and Week 12
Severity of diabetes symptoms
Time frame: Baseline, Week 4, Week 8 and Week 12
Diabetes Specific Quality of Life questionnaire scores
Time frame: Baseline, Week 4, Week 8 and Week 12
Hypoglycemic drug dose
Time frame: Baseline, Week 4, Week 8 and Week 12
Incidence of any adverse events
Time frame: Baseline, Week 4, Week 8 and Week 12
Incidence of severe adverse events
Time frame: Baseline, Week 4, Week 8 and Week 12
Incidence of treatment-related adverse events
Time frame: Baseline, Week 4, Week 8 and Week 12
Incidence of individual adverse events
Time frame: Baseline, Week 4, Week 8 and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 40413050Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Zhou, M.D principal investigator
Jiangxi University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pueraria lobata radix in people with Type 2 Diabetes Mellitus, run by Jiangxi University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhou, M.D (+8618870050733, zhouxu_ebm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06494683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.