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NCT07457632 · ClinicalTrials.gov registry record · Phase 2
Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT07457632 is a Phase 2 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 69 participants.
The verdict
NCT07457632, a Phase 2 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Diabetic macular edema, a complication of diabetes cannot be managed without addressing systemic inflammation. Liver metabolism and functions are implicated in diabetes and evidence suggests that hepatic metabolic dysfunctions are linked to the neuroinflammation and vascular dysfunctions observed in diabetic retinopathy. Nutraceutical supplements like Tauroursodeoxycholate (a bile acid) and modified Qi Ju Di Huang Wan (a traditional Chinese medicine formula) have been found to reduce hepatic and retinal oxidative stress, provide anti-apoptotic, anti-inflammatory, neuroprotective and hepatoprotective effects. This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema.
Interventions
- DRUG placebo capsule
- DIETARY_SUPPLEMENT Tauroursodeoxycholate (TUDCA)
- DIETARY_SUPPLEMENT Traditional Chinese Medicine (mQJDHW)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07457632
The ClinicalTrials.gov registry entry for NCT07457632 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo capsule is the first listed.
NCT07457632 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07457632 about?
NCT07457632 is a clinical study titled "Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.". Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. ...
What is the current status of trial NCT07457632?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2026-07-01. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT07457632?
The interventions under investigation include: placebo capsule (DRUG), Tauroursodeoxycholate (TUDCA) (DIETARY_SUPPLEMENT), Traditional Chinese Medicine (mQJDHW) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07457632?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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