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Ancient herbs meet AI: could a TCM formula slow kidney failure in diabetes?

NCT ID NCT07459946

Disease control Sponsor: Jiazhen Yin Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a Traditional Chinese Medicine (TCM) herbal formula, Jiajian Yishen Xiaozheng Qufeng Granules, combined with AI-driven diagnostics to treat diabetic nephropathy (kidney disease from type 2 diabetes). About 198 adults with mild-to-moderate kidney damage will receive the formula or a placebo in a double-blind trial. The goal is to see if the treatment can reduce protein in urine and slow kidney decline, potentially improving patients' quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Jiajian Yishen Xiaozheng Qufeng Granules (a Traditional Chinese Medicine formula)
What this could lead to
If successful, this could offer a new, non-drug treatment option to slow kidney disease progression and improve quality of life for people with diabetic nephropathy.
What could go wrong
This is an early-stage trial with only 198 participants, and the herbal formula is unlisted in standard drug databases. Results may not apply to all patients, and the treatment's safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meets the clinical diagnostic criteria for diabetic nephropathy; 2. Aged 18-75 years, any gender; 3. eGFR \>45 ml/min/1.73m²; 4. 24-hour urine protein \<2.0 g/day; 5. Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms; 6. Willing to participate in the study, able to attend regular follow-ups, and provide informed consent; 7. Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for ≥1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted. Exclusion Criteria: 1. Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.); 2. Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.); 3. Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.); 4. Critical organ failure (severe diseases of the heart, liver, or lungs); 5. Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study); 6. Drug allergy or clear contraindications (allergic to the study drug or its components); 7. Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements); 8. Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk; 9. Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease diabetic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic renal failure/ kidney disease Diabetic nephropathy type 2

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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Other studies related to the condition(s) this trial covers.