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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07457632
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Tauroursodeoxycholate (TUDCA) — DIETARY_SUPPLEMENT
    TUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA).
  • Traditional Chinese Medicine (mQJDHW) — DIETARY_SUPPLEMENT
    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.
  • placebo capsule — DRUG
    The placebo has no active ingredient.

Study Details

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 Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tauroursodeoxycholate (TUDCA) Arm
    TUDCA is a bile acid that is available as a supplement. It has been found to provide protection in neuroinflammatory and neurodegenerative diseases. Evidence links it to reducing retinopathy in pre-clinical studies.
  • Active Comparator: Traditional Chinese medicine (mQJDHW) Arm
    Participants in this arm will be administered a standard dose of mQJDHW capsules twice daily for six months. mQJDHW, is a popular traditional Chinese medicine (TCM) formula used by TCM practitioners for managing eye diseases. It has been found to improve ocular health in anterior chamber diseases, uveitis, optic neuropathies and diabetic retinopathy. The various components of this formula, 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, have been found to provide neuroprotection, hepatoprotection, and reduce oxidative stress and neuroinflammation. Available in literature is evidence of the beneficial roles of this formula to systemic and retinal health.
  • Placebo Comparator: Control (placebo) Arm
    Participants will receive capsules with no active ingredient twice daily for six months.

Primary Outcome Measure

Change from baseline in macrophage-like cell density (cells/mm²). [ Time Frame: Up to three months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35243
Sandra Owusu, OD
[email protected]
205-222-2837
Sarbodeep Paul
[email protected]
659-253-3319

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By research site
University of Alabama at Birmingham· Birmingham, AL

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