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Can eye scans and herbal medicine fix diabetes brain damage?

NCT ID NCT06813274

Knowledge-focused Sponsor: Hejiang Ye Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how diabetes affects small blood vessels and nerves in the eyes and brain. Researchers will use advanced imaging to detect damage and test a traditional Chinese herbal medicine called Tangshen'an Granules to see if it can help. 160 adults with diabetes will take either the herbal granules or a placebo for a set time, while doctors monitor their vision, brain structure, and thinking skills. The goal is to find better ways to diagnose and treat these complications early.

What this could mean

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

Active substance
Tangshen'an Granules (a blend of herbs) and Ginkgo Leaf Tablets
What this could lead to
If successful, this could provide a new way to diagnose and treat nerve and blood vessel damage in diabetes using eye and brain scans, and support the use of a traditional Chinese medicine.
What could go wrong
This is an early Phase 2 trial with only 160 participants, so results may not apply to everyone. The herbal treatment may not work better than placebo, and side effects are not yet fully known.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

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

Expected to start

Jan 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 70 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: * Participants who comply with the diagnostic criteria for DM according to the World Health Organization in 1999. * Participants who fulfill the diagnostic criteria for diabetic NCI. ③ Participants who diagnosed with the syndrome of kidney deficiency and blood stasis according to TCM syndrome differentiation. ④ Participants who have a glycated hemoglobin(HbA1c) level of ≤9%. ⑤ Participants who are aged between 18 and 70 years inclusive, with no gender preference. ⑥Participants who sign informed consent form. Exclusion Criteria: * Participants exhibiting retinopathy induced by alternative etiological factors (including retinal vein occlusion, age-related macular degeneration(AMD), alongside cognitive impairments stemming from endocrine-metabolic disturbances, sleep disorders. * Participants suffering from acute diabetic complications (such as diabetic ketoacidosis, hyperosmolar hyperglycemic state). * Participants with significant dysfunction in the heart, liver, kidney, or autoimmune disorders. ④Participants unable to cooperate due to mental health issues, intellectual disabilities, or similar conditions that impede their participation in the trial. ⑤Participants who are allergic to the intervention used in this study. ⑥Participants who have engaged in other trials within the past three months or are currently enrolled in another study. ⑦Female participants who are in the process of trying to conceive, are pregnant, or are lactating.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction diabetes mellitus diabetic retinopathy

As listed by the trial registrant

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

Cognitive impairment Diabetes mellitus Diabetic retinopathy Neurovascular coupling

How to take part

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

  1. The places running it

    3 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

  • Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine

    Deyang, Sichuan, 618000, China

  • Guangyuan North Sichuan Diabetes Specialty Hospital

    Guangyuan, Sichuan, 628000, China

  • Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610072, China

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