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NOT YET RECRUITING
NCT07457632
PHASE2

Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2026-07-01

Completion Date

2028-12-31

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Tauroursodeoxycholate (TUDCA)

TUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA).

DIETARY_SUPPLEMENT

Traditional Chinese Medicine (mQJDHW)

The components of this formula are Tribulus terrestris, Paeonia lactiflora, Lycium chinensis, Angelica sinensis, Chrysanthemum morifolium, Paeonia suffruticosa, Dioscorea japonica, Cornus officinalis, Rehmannia glutinosa, Haliotis spp, Alisma plantago-aquatica and Dioscorea oppositifolia.

DRUG

placebo capsule

The placebo has no active ingredient.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States