Type 2 DiabetesNCT07079085
Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This real-world study aims to investigate the association between the consumption of Pueraria lobata radix and adverse events in patients with type 2 diabetes mellitus (T2DM) under special scenarios. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 731 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 29 Oct 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise individuals diagnosed with T2DM. Diagnosis will be established according to international diabetes guidelines, defined as meeting any of the following criteria: a fasting blood glucose (FBG) level ≥126 mg/dL (7.0 mmol/L), a blood glucose level ≥200 mg/dL (11.1 mmol/L) measured 2 hours after a 75-g oral glucose tolerance test, or a glycated hemoglobin (HbA1c) level ≥6.5% (48 mmol/mol).
Who may be able to join
- Diagnosis with T2DM.
- Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).
- Fulfillment of at least one of the following special scenarios: 1) Excessive dosage: Daily PLR intake ≥ twice the maximum dose specified in the Chinese Pharmacopoeia; 2) Long-term consumption: PLR consumption duration ≥ three months with frequency ≥ three times weekly; 3) Advanced age: ≥ 80 years; 4) Pregnancy; 5) Lactation; 6) Allergic constitution: History of any food or drug allergy; 7) Liver dysfunction: Clinical diagnosis of liver cirrhosis or chronic liver failure, or laboratory findings of total bilirubin > 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2 × ULN; 8) Renal insufficiency: Clinical diagnosis of diabetic nephropathy or chronic nephritis with renal function impairment, or serum creatinine > 120% of ULN.
- Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.
Who cannot join
- Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
- Use of PLR compound preparations (e.g., puerarin injection).
- Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330006
About this study
Official title: Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes: A Real-World Study
This real-world study aims to investigate the association between the consumption of Pueraria lobata radix and adverse events in patients with type 2 diabetes mellitus (T2DM) under special scenarios. By retrospectively analyzing the clinical data of patients with T2DM, we will evaluate the safety profile of Pueraria lobata radix in different special populations, identify potential risk factors, and provide evidence-based support for the safe consumption and clinical use of Pueraria lobata radix.
Read the detailed description
Pueraria lobata radix (PLR), the dried root of Pueraria lobata (Willd.) Ohwi (Family Leguminosae), is an herb with both medicinal and edible applications, historically utilized for treating diabetes. Recent research advances regarding its bioactive constituents have progressively validated PLR's potential efficacy in the adjunctive therapy of type 2 diabetes mellitus (T2DM). Animal studies demonstrate that multiple active compounds within PLR, such as puerarin and polysaccharides, exert significant hypoglycemic effects. The underlying mechanisms include improvement of insulin sensitivity, reduction of insulin resistance, enhancement of glucose tolerance, and protection of pancreatic β-cell function. Based on this evidence, puerarin injections (primarily composed of the standardized extract puerarin) are clinically employed for treating T2DM and its complications, exhibiting substantial therapeutic benefits. Clinical studies further confirm that PLR dietotherapy at conventional doses effectively assists glycemic control with a favorable safety profile. Owing to its dual designation as both a medicine and food, PLR has gained widespread adoption in the daily dietary management of T2DM patients.
However, significant uncertainties persist concerning PLR's safety under non-standard consumption patterns. For instance, some patients may consume PLR products at high doses, for extended durations, or irregularly. Furthermore, consumption occurs among special populations, such as children, pregnant or lactating women, and the elderly. Such usage patterns and dosages may substantially deviate from established recommendations. The absence of systematic safety assessments for these scenarios leaves potential risks unclarified. This safety concern is exacerbated within unregulated market environments; the lack of restrictions on PLR purchase or intake could diminish patient awareness regarding safe dosing practices, thereby elevating risks associated with non-standard use.
To address these gaps, this study will conduct a retrospective real-world investigation to systematically evaluate the safety of PLR under special consumption scenarios within T2DM populations.
- Conditions
- Type 2 Diabetes
- Keywords
- Pueraria lobata radix, Ge Gen, Type 2 diabetes mellitus, Safety, Real-world study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pueraria lobata radix group | This group includes patients with T2DM who consumed Pueraria lobata radix in any special scenarios. | |
| Control group | This group includes patients with T2DM who did not consume Pueraria lobata radix in any special scenarios. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of individual adverse events
The between-group differences in the incidence of individual adverse events will be compared across the eight predefined special consumption scenarios: 1) excessive dosage, 2) long-term consumption, 3) advanced age, 4) pregnancy, 5) lactation, 6) allergic constitution, 7) liver dysfunction, and 8) renal insufficiency.
Measured: Collect data from the past 6 months for each sample, with the sample sources spanning a two-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jul 2025
- Primary completion29 Oct 2026
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 731 participants (actual)
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
- 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
- NCT07079085
- Sponsor's protocol ID
- JXUCM-DIET-02
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes: A Real-World Study
- ClinicalTrials.gov ID
- NCT07079085
- Acronym / sponsor ID
- JXUCM-DIET-02
- Conditions
- Type 2 Diabetes
- Keywords
- Pueraria lobata radix, Ge Gen, Type 2 diabetes mellitus, Safety, Real-world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 29 Oct 2026 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 22 Jul 2025 (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.
This real-world study aims to investigate the association between the consumption of Pueraria lobata radix and adverse events in patients with type 2 diabetes mellitus (T2DM) under special scenarios. By retrospectively analyzing the clinical data of patients with T2DM, we will evaluate the safety profile of Pueraria lobata radix in different special populations, identify potential risk factors, and provide evidence-based support for the safe consumption and clinical use of Pueraria lobata radix.
Detailed description
Pueraria lobata radix (PLR), the dried root of Pueraria lobata (Willd.) Ohwi (Family Leguminosae), is an herb with both medicinal and edible applications, historically utilized for treating diabetes. Recent research advances regarding its bioactive constituents have progressively validated PLR's potential efficacy in the adjunctive therapy of type 2 diabetes mellitus (T2DM). Animal studies demonstrate that multiple active compounds within PLR, such as puerarin and polysaccharides, exert significant hypoglycemic effects. The underlying mechanisms include improvement of insulin sensitivity, reduction of insulin resistance, enhancement of glucose tolerance, and protection of pancreatic β-cell function. Based on this evidence, puerarin injections (primarily composed of the standardized extract puerarin) are clinically employed for treating T2DM and its complications, exhibiting substantial therapeutic benefits. Clinical studies further confirm that PLR dietotherapy at conventional doses effectively assists glycemic control with a favorable safety profile. Owing to its dual designation as both a medicine and food, PLR has gained widespread adoption in the daily dietary management of T2DM patients.
However, significant uncertainties persist concerning PLR's safety under non-standard consumption patterns. For instance, some patients may consume PLR products at high doses, for extended durations, or irregularly. Furthermore, consumption occurs among special populations, such as children, pregnant or lactating women, and the elderly. Such usage patterns and dosages may substantially deviate from established recommendations. The absence of systematic safety assessments for these scenarios leaves potential risks unclarified. This safety concern is exacerbated within unregulated market environments; the lack of restrictions on PLR purchase or intake could diminish patient awareness regarding safe dosing practices, thereby elevating risks associated with non-standard use.
To address these gaps, this study will conduct a retrospective real-world investigation to systematically evaluate the safety of PLR under special consumption scenarios within T2DM populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pueraria lobata radix group | – | –This group includes patients with T2DM who consumed Pueraria lobata radix in any special scenarios. |
| Control group | – | –This group includes patients with T2DM who did not consume Pueraria lobata radix in any special scenarios. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise individuals diagnosed with T2DM. Diagnosis will be established according to international diabetes guidelines, defined as meeting any of the following criteria: a fasting blood glucose (FBG) level ≥126 mg/dL (7.0 mmol/L), a blood glucose level ≥200 mg/dL (11.1 mmol/L) measured 2 hours after a 75-g oral glucose tolerance test, or a glycated hemoglobin (HbA1c) level ≥6.5% (48 mmol/mol).
Key inclusion criteria (4 listed)
- Diagnosis with T2DM.
- Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).
- Fulfillment of at least one of the following special scenarios: 1) Excessive dosage: Daily PLR intake ≥ twice the maximum dose specified in the Chinese Pharmacopoeia; 2) Long-term consumption: PLR consumption duration ≥ three months with frequency ≥ three times weekly; 3) Advanced age: ≥ 80 years; 4) Pregnancy; 5) Lactation; 6) Allergic constitution: History of any food or drug allergy; 7) Liver dysfunction: Clinical diagnosis of liver cirrhosis or chronic liver failure, or laboratory findings of total bilirubin > 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2 × ULN; 8) Renal insufficiency: Clinical diagnosis of diabetic nephropathy or chronic nephritis with renal function impairment, or serum creatinine > 120% of ULN.
- Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.
Key exclusion criteria (3 listed)
- Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
- Use of PLR compound preparations (e.g., puerarin injection).
- Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of individual adverse events
Time frame: Collect data from the past 6 months for each sample, with the sample sources spanning a two-year period
The between-group differences in the incidence of individual adverse events will be compared across the eight predefined special consumption scenarios: 1) excessive dosage, 2) long-term consumption, 3) advanced age, 4) pregnancy, 5) lactation, 6) allergic constitution, 7) liver dysfunction, and 8) renal insufficiency.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Jiangxi University of Traditional Chinese Medicine at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of individual adverse events (time frame: Collect data from the past 6 months for each sample, with the sample sources spanning a two-year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.