Ancient herbal formula put to the test against diabetic kidney disease

NCT ID NCT07698223

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Recruiting now
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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.
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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
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First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial investigates whether adding Naoxintong Capsule, a traditional Chinese medicine made from 16 herbal and animal ingredients, to standard therapy can slow the progression of diabetic nephropathy in people with type 2 diabetes. The study involves 410 participants who will receive either the capsule or a placebo for 12 months. The main goal is to measure the annual rate of kidney function decline, along with other kidney and heart health outcomes.

What this could mean

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

Active substance
Naoxintong Capsule (a blend of 16 herbal and animal ingredients)
What this could lead to
If effective, this could offer a new add-on therapy to slow kidney decline and reduce cardiovascular risk in people with diabetic nephropathy.
What could go wrong
This is a Phase 4 trial with a moderate sample size. The herbal mixture is complex, and results may not generalize beyond the studied population. Side effects from the multiple ingredients are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 410 people

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

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 years and older

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. Age \>= 18 years. 2. Meets the diagnostic criteria for Type 2 diabetic nephropathy, defined as: 1. Confirmed diagnosis of Type 2 diabetes mellitus; AND 2. At least one of the following: urinary albumin-to-creatinine ratio (UACR) \>= 30 mg/g, or eGFR \< 60 mL/min/1.73m\^2, confirmed by repeat testing (interval \>= 3 months), after excluding transient factors such as acute kidney injury, dehydration, infection, or heart failure; OR 3. Renal biopsy confirmed as isolated diabetic nephropathy; AND 4. Exclusion of other primary or secondary kidney diseases. 3. 24-hour urinary protein excretion \>= 0.5 g and \< 3.5 g. 4. Estimated glomerular filtration rate (eGFR) \>= 45 mL/min/1.73m\^2. 5. On a stable dose of ACE inhibitor (ACEI) or Angiotensin II receptor blocker (ARB) therapy for at least 8 weeks prior to enrollment. If SGLT2 inhibitors, mineralocorticoid receptor antagonists (MRA), or GLP-1 receptor agonists are being used, the dose must have been stable for at least 4 weeks prior to enrollment and remain unchanged during the study period. Patients not currently using these agents must not initiate them during the study. 6. Signed informed consent form. Exclusion Criteria: 1. Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young). 2. Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology. 3. Decline in eGFR of \> 30% within the past 3 months. 4. Persistent serum potassium \> 5.5 mmol/L. 5. Diagnosis of hemorrhagic cardiovascular or cerebrovascular disease within the past 3 months. 6. Known allergy or hypersensitivity to any component of Naoxintong Capsule or placebo; pregnant or lactating women. 7. Participation in another drug or medical device clinical trial within the past 6 months. 8. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the clinical trial (e.g., severe hepatic dysfunction, life expectancy \< 1 year).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, China

  • Chinese PLA General Hospital, First Medical Center

    Beijing, Beijing Municipality, 100853, China

  • Daping Hospital, Army Medical University

    Chongqing, Chongqing Municipality, China

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, China

  • Longhua Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, China

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