Ancient herbal formula put to the test against diabetic kidney disease
NCT ID NCT07698223
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 410 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
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Chinese PLA General Hospital, First Medical Center
Beijing, Beijing Municipality, 100853, China
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Daping Hospital, Army Medical University
Chongqing, Chongqing Municipality, China
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First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
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Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill replace the needle for anemia in diabetic kidney disease?
- Can a milk protein shield kidneys from diabetes damage?
- Fig leaf tea may shield kidneys from diabetes damage — a trial puts it to the test
- Baking soda may cut kidney risk in type 1 diabetes
- Could a herbal tablet protect kidneys in diabetes?
- Kidney hope: two-pill combo may slow damage in diabetic patients